MAUDE Adverse Event Report: ALERE SAN DIEGO ALERE HCG CASSETTE (25MIU/ML) 40T; HCG PREGNANCY TEST

Model Number	92217
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results pending completion of the investigation.
Event or Problem Description
The customer reported a false negative urine result after performing an hcg test with a patient on (b)(6) 2020.The patient allegedly performed 8 pregnancy tests at home which were positive.A serum sample was drawn and the result was 224 iu/ml.A clinician retested the urine specimen and observed that the test result was positive.The controls performed as expected, technique and procedure were followed.Subsequently, the care coordinator of the medical center ran the same urine sample on 10 hcg tests with positive results.There was no treatment, procedure or medication changed for the patient due to this event.
Additional Manufacturer Narrative
D10: new date of 04/24/2020.H3: changed to yes.Investigation conclusion: retained and returned devices from the reported lot number were tested with cut-off (25 miu/ml) and middle positive standards (100 miu/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 either retention or returned product.Complaints are tracked and trended on a monthly basis.Per the package insert, 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: ALERE HCG CASSETTE (25MIU/ML) 40T
• Common Device Name: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9975 summers ridge rd; san diego, ca
• MDR Report Key: 9968358
• Report Number: 2027969-2020-00018
• Device Sequence Number: 19603581
• Product Code: JHI
• UDI-Device Identifier: 10815845020109
• UDI-Public: (01)10815845020109(17)210630(10)HCG9072113
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K993317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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: 06/30/2021
• Device Model Number: 92217
• Device Lot Number: HCG9072113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2020
• Initial Date Received by Manufacturer: 04/03/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1