MAUDE Adverse Event Report: ALERE SCARBOROUGH INC. ALERE DETERMINE HIV 1/2 AG/AB COMBO; IVD FOR HIV AG/AB

Catalog Number	7D2648
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No kit lot number was provided for a specific investigation.No sample was returned for further testing, and no additional information was provided.A review of complaint trends revealed that all of the alere determine (b)(6) combo lots are performing according to label claims.The exact root cause of the reported issue could not be determined.The results obtained may possibly be related to the patient sample.The sample may have contained specific substances which may have affected the results.The available evidence suggests that the device is performing within labeled claims.
Event or Problem Description
Customer reported (via a customer survey) a false (b)(6) ab result on a serum sample tested with the alere determine hiv 1/2ag/ab combo.Unspecified confirmatory test done at quest was negative.The date of event was not provided.No additional patient information was provided.There is insufficient information to determine if a malfunction occurred.Patient gender, pregnancy status, treatment and patient outcome were unknown.At the time of the event there was no indication of a product malfunction based on the information provided and assessed by alere scarborough, inc.; however, this mdr is a retrospective filing in response to an observation from an fda inspection conducted (b)(6) 2018 at alere (b)(6).

• Brand Name: ALERE DETERMINE HIV 1/2 AG/AB COMBO
• Common Device Name: IVD FOR HIV AG/AB
• Manufacturer (Section D): ALERE SCARBOROUGH INC.; 10 southgate road; scarborough ME 04074
• MDR Report Key: 7587587
• Report Number: 1221359-2018-00190
• Device Sequence Number: 179278
• Product Code: MZF
• UDI-Device Identifier: 10811877010323
• UDI-Public: 011081187701032310090407
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: BP120037-0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2018

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 Catalogue Number: 7D2648
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1