MAUDE Adverse Event Report: ALERE SAN DIEGO HENRY SCHEIN HCG URINE CASSETTE 100T; HCG PREGNANCY TESTS

Model Number	FHC-102
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/12/2018
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 san diego.Alere san diego 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 san diego (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 observation was not replicated with retention products.Retention products were tested with 29 clinically negative urine samples and the results indicated all devices showed correct negative results at 3-4 minutes.No false positive results were obtained during testing.Returned product was tested with in-house clinically negative donor urine and results were read at 3-4 minutes.All devices showed expected negative results at read time.No false positive results were obtained during testing.The customer's complaint was not replicated.Manufacturing batch record review did not uncover any abnormalities.The root cause could not be determined based on the information provided.
Event or Problem Description
It was reported by the distributor that the hcg cassette are having false positive results.Although requested, no other information has been received.

• Brand Name: HENRY SCHEIN HCG URINE CASSETTE 100T
• Common Device Name: HCG PREGNANCY TESTS
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 9121588
• Report Number: 2027969-2019-00457
• Device Sequence Number: 2332803
• Product Code: JHI
• UDI-Device Identifier: 10304040024116
• UDI-Public: (01)10304040024116(17)190131(10)HCG7010089
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K993317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• 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: 01/31/2019
• Device Model Number: FHC-102
• Device Catalogue Number: 9004074
• Device Lot Number: HCG7010089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1