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

Catalog Number	7D2648
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the investigation is still in process, a review of the complaints reported as (b)(6) patient results (confirmed and unconfirmed, conflicting results) related to kit lot 118805 showed that the complaint rate is (b)(4).A supplemental report will be submitted after completion.
Event or Problem Description
A customer reported that following a needle stick involving an employee, a false positive result with the alere determine (b)(6) combo test performed on (b)(6) 2021 was observed.Following a needle stick to an employee (no details provided) from a needle used on a (b)(6) patient, the source patient was tested with the alere determine (b)(6) combo test.Serum sample was added by 50 ml pipette to the tests.The source patient test generated (b)(6) results.Confirmation testing for the source patient with the (b)(6) test performed on (b)(6) 2021 generated (b)(6) results.The customer reported that the source patient did not have any symptoms and testing the source patient was protocol for a needlestick.The customer was unaware of whether the source patient received art.No additional information related to the employee who experienced the needle stick has been provided.The customer confirmed there was no death or serious injury based on the test results.Per the alere determine (b)(6) combo product insert limitations: (b)(6).When the source patient is (b)(6) and receives unnecessary short-term art treatment, the risk of short- and medium-term toxicity with the current recommended art prophylaxis regimen is primarily transient metabolic abnormalities which appear to be primarily mild and reversible after treatment is interrupted.As the sex and/or pregnancy status of the employee who experienced the needle stick is unknown, given that the risk of short and medium-term toxicity to a possible fetus is unknown, this case is reportable.
Additional Manufacturer Narrative
Additional/corrected information: abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue, however it could be attributed to the specific patient sample.The sample may have contained specific substances which may have affected the results.According to the package insert, specimens from individuals with toxoplasma igg, human anti-mouse antibodies, rheumatoid factor, elevated triglycerides (above 600 mg/dl), herpes simplex virus infection, hospitalized and cancer patients may give false positive test results.

• Brand Name: DETERMINE HIV - 1/2 AG/AB COMBO
• Common Device Name: IVD FOR HIV 1/2 AG/AB
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH INC.; 10 southgate road; scarborough ME 04074
• MDR Report Key: 11309499
• Report Number: 1221359-2021-00243
• Device Sequence Number: 1167513
• Product Code: MZF
• UDI-Device Identifier: 10811877010293
• UDI-Public: 011081187701029310118805
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: BP120037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2021

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: 05/11/2021
• Device Catalogue Number: 7D2648
• Device Lot Number: 118805
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1