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

Model Number	FHC-102
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/30/2019
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 observation was not replicated in-house with retention and return products.Retention and return devices were tested with in-house clinical hcg negative urine samples.All hcg results were negative at read time and met qc specifications.No false positive results were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities.The customer did not provide patient information or information regarding the testing technique.Because return specimen was not available, further investigation was not pursued.A root cause could not be determined based on the information provided.
Event or Problem Description
It was reported by the distributor that false positives are occurring with the hcg urine cassette tests at the obgyn facility.Although requested, no further information has been received and no adverse event has been reported.

• Brand Name: HENRY SCHEIN HCG URINE CASSETTE 100T
• Common Device Name: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 9130547
• Report Number: 2027969-2019-00529
• Device Sequence Number: 2312728
• Product Code: JHI
• UDI-Device Identifier: 10304040024116
• UDI-Public: (01)10304040024116(17)181130(10)HCG6120096
• 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): 09/27/2019

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: 11/30/2018
• Device Model Number: FHC-102
• Device Catalogue Number: 9004074
• Device Lot Number: HCG6120096
• 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: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1