MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HENRY SCHEIN HCG COMBO; HCG PREGNANCY TEST

Model Number FHC-202K

Device Problem False Negative Result (1225)

Patient Problem Spontaneous Abortion (4514)

Event Date 01/10/2023

Event Type  Injury  

Event Description

The customer reported a false negative result when testing with the henry schein hcg combo cassette (sensitivity of 25 miu/ml).A patient urine sample was tested as a screen prior to placement of an iud contraceptive.The urine sample was freshly voided, but was not a first morning sample.The result was read at the appropriate 3-minute read time, and was interpreted as negative, after which the iud was implanted.Approximately 15 minutes after the patient left the office, a medical assistant noticed that the result on the hcg combo cassette had changed from negative to positive, and the patient was called back for confirmatory testing.The quantitative blood test was positive with a result of 82 miu/ml, and the iud was subsequently removed.The patient experienced a miscarriage.The doctor continued to track the patient¿s hcg level, which was 4 miu/ml as of (b)(6) 2023.

Manufacturer Narrative

Investigation conclusion to date (pending receipt and testing of return product): retained devices from the reported lot number were tested with qc cut-off positive urine standards (25 miu/ml) and high-hcg clinical urine samples (226.08¿238.92 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.The total lot size for lot hcg2032009 is (b)(4) devices, and no other result-related complaints have been received for the lot or any other lot manufactured with the same semi-finished test strip.Manufacturing batch record review for the finished product, semi-finished product, and test strip components did not uncover any relevant non-conformances; 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.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 urine or serum specimen should be collected 48 hours later and tested.Very low levels of hcg (less than 50 miu/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 urine or serum specimen collected 48 hours later.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.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.Product is expected and is pending return from the customer.

Manufacturer Narrative

Update to d9: product received on 10-feb-2023.Investigation conclusion: retained and returned devices from the reported lot number were tested with qc cut-off positive urine standards (25 miu/ml) and high-hcg clinical urine samples (226.08¿238.92 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.The total lot size for lot hcg2032009 is (b)(4) devices, and no other result-related complaints have been received for the lot or any other lot manufactured with the same semi-finished test strip.Manufacturing batch record review for the finished product, semi-finished product, and test strip components did not uncover any relevant non-conformances; 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 either retention or returned product.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 urine or serum specimen should be collected 48 hours later and tested.¿ very low levels of hcg (less than 50 miu/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 urine or serum specimen collected 48 hours later.¿ 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.¿ 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.

Event Description

The customer reported a false negative result when testing with the henry schein hcg combo cassette (sensitivity of 25 miu/ml).A patient urine sample was tested as a screen prior to placement of an iud contraceptive.The urine sample was freshly voided, but was not a first morning sample.The result was read at the appropriate 3-minute read time, and was interpreted as negative, after which the iud was implanted.Approximately 15 minutes after the patient left the office, a medical assistant noticed that the result on the hcg combo cassette had changed from negative to positive, and the patient was called back for confirmatory testing.The quantitative blood test was positive with a result of 82 miu/ml, and the iud was subsequently removed.The patient experienced a miscarriage.The doctor continued to track the patient¿s hcg level, which was 4 miu/ml as of (b)(6) 2023.

• Brand Name: HENRY SCHEIN HCG COMBO
• Type of Device: HCG PREGNANCY TEST
• 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: 16358992
• MDR Text Key: 309366455
• Report Number: 2027969-2023-00013
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 10304040024123
• UDI-Public: (01)10304040024123(17)240229(10)HCG2032009
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: FHC-202K
• Device Catalogue Number: 9004075
• Device Lot Number: HCG2032009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 44 YR
• Patient Sex: Female