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

Model Number	92217
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of the event, there was no indication of a reportable malfunction based on information provided and assessed by alere (b)(4).Alere (b)(4) updated reporting decisions and conducted a retrospective review of complaints against the updated reporting decisions.This mdr is a retrospective filing that was identified during this retrospective review activity associated with an observation from an fda inspection conducted in january 2019 at alere (b)(4) (reference eir (b)(4)).The awareness date is based on updated reporting decisions and completion of the retrospective review activity.There is no new or increased trend based on this retrospective review activity.Investigation results: the customer's results were not replicated in-house with returned and retention products of the reported lot.Returned and retention products were tested with a low-hcg concentration urine standard below the qc cutoff and hcg-negative urine from clinical donors.All devices produced expected negative results at the read time.The product met qc release specifications.False positive results were not observed during the investigation.Manufacturing batch record review did not uncover any abnormalities.A root cause could not be determined from the information provided by the customer.
Event or Problem Description
It was reported that a customer received a false positive result when using an alere hcg cassette.The results confirmed via quant (b)(6) 2017 hcg = 3.79 miu/ml using vitros 3600.The customer stated their facility reports patients as not pregnant if hcg less than 6.15 miu/ml.No other patient information was received.Troubleshooting occurred with a discussion about the issue and potential factors per the pi, storage, sampling, and technique.

• Brand Name: ALERE HCG CASSETTE (25MIU/ML) 40T
• Common Device Name: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 9114344
• Report Number: 2027969-2019-00396
• Device Sequence Number: 16817523
• Product Code: JHI
• UDI-Device Identifier: 10815845020109
• UDI-Public: (01)10815845020109(17)180731(10)HCG6080203
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/24/2019

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: 06/30/2018
• Device Model Number: 92217
• Device Lot Number: HCG6070127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1