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

Model Number	FHC-A202
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results pending completion of the investigation.
Event or Problem Description
The customer reported receiving a total of 4 false positive results for 1 patient while using fisher sure-vue hcg cassettes.The patient initially presented for a hip procedure on (b)(6) 2024, prior to the procedure, the patient provided a fresh urine sample which was tested on the fisher sure-vue hcg cassette lot 0000702333.The result was read at 3 minutes which was positive.The patient was then tested again using another device from the same lot using a serum sample.The results were read at 5 minutes and an additional positive hcg result was obtained.Following the second positive hcg result, an unknown sample type was collected at 0935 for quantitative testing and the test yielded a value of 5.8 (units not specified).As a result of the positive hcg results, the patient's hip procedure was rescheduled.The patient later presented on (b)(6) 2024 for additional testing, the patient provided a fresh urine sample which was tested on the fisher sure-vue hcg cassette lot 0000788119.The result was read at 3 minutes which was positive.The patient was then tested again using another device from the same lot (0000788119) using a serum sample.The results were read at 5 minutes and an additional positive hcg result was obtained.Following these positive hcg results, an unknown sample type was collected at 1525 for quantitative testing and the test yielded a value of 7.6 (units not specified).No adverse event reported.See mdr 2027969-2024-00071 for the reported issues on lot 0000788119.
Event or Problem Description
The customer reported receiving a total of 4 false positive results for 1 patient while using fisher sure-vue hcg cassettes.The patient initially presented for a hip procedure on (b)(6) 2024, prior to the procedure, the patient provided a fresh urine sample which was tested on the fisher sure-vue hcg cassette lot: 0000702333.The result was read at 3 minutes which was positive.The patient was then tested again using another device from the same lot using a serum sample.The results were read at 5 minutes and an additional positive hcg result was obtained.Following the second positive hcg result, an unknown sample type was collected at 0935 for quantitative testing and the test yielded a value of 5.8 (units not specified).As a result of the positive hcg results, the patient's hip procedure was rescheduled.The patient later presented on (b)(6) 2024 for additional testing, the patient provided a fresh urine sample which was tested on the fisher sure-vue hcg cassette lot: 0000788119.The result was read at 3 minutes which was positive.The patient was then tested again using another device from the same lot: (0000788119) using a serum sample.The results were read at 5 minutes and an additional positive hcg result was obtained.Following these positive hcg results, an unknown sample type was collected at 1525 for quantitative testing and the test yielded a value of 7.6 (units not specified).No adverse event reported.See mdr 2027969-2024-00071 for the reported issues on lot: 0000788119.
Additional Manufacturer Narrative
Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical urine, hcg-negative clinical serum samples, 4miu/ml hcg urine sample and 2miu/ml hcg serum samples.The results of the devices tested using clinically negative samples were read at 3 and 4 minutes for urine and 5 and 6 minutes for serum.Low hcg (4miu/ml hcg urine and 2miu/ml hcg serum) samples were read at 4 and 6 minutes respectively.All devices yielded valid negative results.No false positive 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-conformance's 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, please note a mixture of positive and negative results could be observed near cut-off.Complaints are tracked and trended on a monthly basis.Per the package insert: very low levels of hcg (less than 50miu/ml) are present in urine and serum specimen shortly after implantation.However, because a significant number of first trimester pregnancies terminate for natural reasons, a test result that is weakly positive should be confirmed by retesting with a first morning serum or urine specimen collected 48 hours later.A number of conditions other than pregnancy, including trophoblastic disease and certain non-trophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated levels of hcg.Therefore, the presence of hcg in serum or urine specimen should not be used to diagnose pregnancy unless these conditions have been ruled out.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.This test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

• Brand Name: FISHER SURE-VUE HCG STAT SERUM/URINE
• 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: 19538463
• Report Number: 2027969-2024-00070
• Device Sequence Number: 6425533
• Product Code: JHI
• UDI-Device Identifier: 00613647000571
• UDI-Public: (01)00613647000571(17)250401(10)0000702333
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2025
• Device Model Number: FHC-A202
• Device Catalogue Number: 23900530
• Device Lot Number: 0000702333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2023
• 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
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White