MAUDE Adverse Event Report: BIO-RAD LABORATORIES GENETIC SYSTEMS HIV-1/HIV-2 PLUS O EIA; IVD, EIA

Catalog Number	25256
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	08/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On september 19, 2019 bio-rad technical support received a complaint forwarded from a distribution partner about an incident that happened at customer facility.The initial complaint was for an increase in initially reactive (ir) results that did not repeat in secondary testing using the bio-rad gs hiv-1/hiv-2 plus o assay.After a preliminary investigation it was found that the ir results in question all came from one plate run on (b)(6) 2019.Further investigation into the issue revealed that the results in question were donor samples that were, due to user error, inadvertently run in null strips in rows 9-12 on the test plate.The customer's practice is to use previously tested strips that have been cleaned as null strips.Previously used strips are marked with a black line across the bottom of the strip to indicate them as null.The package insert states that the operator should "take care when assembling partial plates with coated and uncoated (null) strips, as automated systems cannot distinguish between the strips and will report results for all wells that are assigned a sample id number (even if a null strip is inadvertently placed where sample ids have been assigned)." it is likely that when these strips were read by the photometer at the end of the run the black line caused the elevated od reading and the subsequent ir result.Of the 31 samples run in null strips, 28 were ir and were retested.However, there were 3 non-reactive results on strip 12 of the plate that were not retested.Those results were erroneously accepted by the user, and the donor units were released from the donor center for use.On september 27, 2019 additional information was received that indicated that all three of the units that were released as hiv non-reactive had been transfused.Furthermore, since the customer could not determine if the slightly elevated ods in row 8 were due to the use of a null strip or an assay strip from the kit, they decided to expand their recall to include the 8 samples run in row 8 of the test plate.In total, the customer is recalling 11 donor units due to user error for improper hiv testing and will submit a biologic product deviation report.

• Brand Name: GENETIC SYSTEMS HIV-1/HIV-2 PLUS O EIA
• Common Device Name: IVD, EIA
• Manufacturer (Section D): BIO-RAD LABORATORIES; 6565 185th ave ne; redmond WA 98052
• MDR Report Key: 9187846
• Report Number: 3022521-2019-00002
• Device Sequence Number: 3146474
• Product Code: MZF
• UDI-Device Identifier: 00847865001953
• UDI-Public: 00847865001953
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: BL125030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 25256
• Device Lot Number: 102PBB-50
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other