MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. SURE-VUE SERUM/URINE HCG-STAT; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number	FHC-A202
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation conclusion (final conclusion pending completion of return testing): retained devices from the reported lot number were tested with qc cut-off urine standards (20 miu/ml) and high-hcg clinical urine samples (200.77¿270.50 iu/ml).The results were read at 3 minutes and all devices yielded the expected positive results.No false negative results were observed during in-house testing.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Manufacturing batch record review did not uncover any relevant non-conformances and found that the lot met quality control specifications.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.A root cause could not be determined from the available information as the reported issue was not replicated during testing of retention product.However, complaint details indicate that the patient would have been approximately three and a half weeks pregnant at the time of the initial negative result.Given the gestational age of the pregnancy, it is possible that the hcg concentration was below the level of detection of this device.However, this cannot be confirmed as quantitative testing was not performed at the time.Complaints are tracked and trended on a monthly basis.Per the package insert: very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg.If pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.False negative results may occur when the levels of hcg are below the sensitivity level of the test.When pregnancy is still suspected, a first morning serum or urine specimen should be collected 48 hours later and tested.This test reliably detects intact hcg up to 500,000 miu/ml.It does not reliably detect hcg degradation products, including free-beta hcg and beta core fragments.Quantitative assays used to detect hcg may detect hcg degradation products and therefore may disagree with the results of this rapid test.As with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (hama) in the specimen.Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain hama.Such specimens may cause false positive or false negative results.
Event or Problem Description
The customer reported a false negative result when testing a patient urine sample using the sure-vue serum/urine hcg-stat.The patient had been experiencing abdominal pain for over a year, and following the negative hcg result the patient underwent a laparoscopic cholecystectomy with general anesthesia.The patient took an at-home pregnancy test 19 days after the cholecystectomy with a positive result, which was confirmed at the clinic facility.The patient was determined to have been three and a half weeks pregnant at the time of the negative result, however quantitative testing was not performed at the time.While it is unknown whether the hcg concentration of the sample was actually above the level of detection of the sure-vue serum/urine hcg-stat, this is conservatively being considered a false negative.The pregnancy was considered viable as of on (b)(6) 2024; no adverse outcomes were reported.However, due to the potential for harm to the fetus due to exposure to anesthesia, this will be considered an other serious/important medical event.
Additional Manufacturer Narrative
Investigation conclusion: retained and returned devices from the reported lot number were tested with qc cut-off urine standards (20 miu/ml) and high-hcg clinical urine samples (200.77¿270.50 iu/ml).The results were read at 3 minutes and all devices yielded the expected positive results.No false negative results were observed during in-house testing.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Manufacturing batch record review did not uncover any relevant non-conformances and found that the lot met quality control specifications.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.A root cause could not be determined from the available information as the reported issue was not replicated during testing of retention product.However, complaint details indicate that the patient would have been approximately three and a half weeks pregnant at the time of the initial negative result.Given the gestational age of the pregnancy, it is possible that the hcg concentration was below the level of detection of this device.However, this cannot be confirmed as quantitative testing was not performed at the time.Complaints are tracked and trended on a monthly basis.Per the package insert: ¿ very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg.If pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.¿ false negative results may occur when the levels of hcg are below the sensitivity level of the test.When pregnancy is still suspected, a first morning serum or urine specimen should be collected 48 hours later and tested.¿ this test reliably detects intact hcg up to 500,000 miu/ml.It does not reliably detect hcg degradation products, including free-beta hcg and beta core fragments.Quantitative assays used to detect hcg may detect hcg degradation products and therefore may disagree with the results of this rapid test.¿ as with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (hama) in the specimen.Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain hama.Such specimens may cause false positive or false negative results.
Event or Problem Description
The customer reported a false negative result when testing a patient urine sample using the sure-vue serum/urine hcg-stat.The patient had been experiencing abdominal pain for over a year, and following the negative hcg result the patient underwent a laparoscopic cholecystectomy with general anesthesia.The patient took an at-home pregnancy test 19 days after the cholecystectomy with a positive result, which was confirmed at the clinic facility.The patient was determined to have been three and a half weeks pregnant at the time of the negative result, however quantitative testing was not performed at the time.While it is unknown whether the hcg concentration of the sample was actually above the level of detection of the sure-vue serum/urine hcg-stat, this is conservatively being considered a false negative.The pregnancy was considered viable as of 01-feb-2024; no adverse outcomes were reported.However, due to the potential for harm to the fetus due to exposure to anesthesia, this will be considered an other serious/important medical event.

• Brand Name: SURE-VUE SERUM/URINE HCG-STAT
• Common Device Name: VISUAL, PREGNANCY HCG, PRESCRIPTION USE
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9942 mesa rim rd; san diego CA 92121
• Manufacturer Contact: monika burrell ; 9942 mesa rim rd; san diego, CA 92121 ; 8588052506
• MDR Report Key: 18708313
• Report Number: 2027969-2024-00021
• Device Sequence Number: 7271649
• Product Code: JHI
• UDI-Device Identifier: 00613647000571
• UDI-Public: (01)00613647000571(17)250705(10)0000755094
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K062361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/05/2025
• Device Model Number: FHC-A202
• Device Catalogue Number: 23900530
• Device Lot Number: 0000755094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female