MAUDE Adverse Event Report: BIO-RAD LABORATORIES GS HIV COMBO AG/AB EIA

Catalog Number	26217
Health Effect - Clinical Code	Emotional Changes (1831)
Date of Event	04/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Bio-rad technical support was contacted by (b)(6) hospital on 4/12/2018, to report that on (b)(6) 2018 a patient sample was tested with gs hiv combo ag/ab eia (lot 159mjj-02, exp.06/08/2018), which gave an initial (b)(6).The sample was then repeated on (b)(6) 2018 in duplicate with gs hiv combo ag/ab eia (lot 159mjj-02, exp.06/08/2018); both results were (b)(6).The initial sample was also tested on (b)(6) 2018 on the geenius which showed (b)(6) present, (b)(6) as the final interpretation.The customer reported that the patient was admitted to the psychiatric unit due to her reaction after receiving the initial (b)(6) test results.The customer also reported that the patient is/has been a psychiatric patient.The patient requested a retest, and was redrawn on (b)(6) 2018.The results for the second sample for gs hiv combo ag/ab eia (lot 101njj-02, exp.01/12/2018) gave (b)(6) results.The customer had a third sample collected from the patient on (b)(6) 2018, with a pseudo chain of custody.The results for the third sample for gs hiv combo ag/ab eia (lot 101njj-02, exp.01/12/2018) gave (b)(6) results.Nat testing was performed on the second and third samples collected from the patient, which gave the results of not detected.The customer reported that the patient has been informed that they are (b)(6).The customer performed an investigation to determine if the sample was mislabeled, and was unable to find substantial evidence that the sample was mislabeled.An investigation using serial dilution on gs hiv combo ag/ab eia, geenius hiv-1/2 assay, and hiv-1 western blot, by bio-rad laboratories product support, on the samples provided by the customer was able to determine that the initial sample was more than likely compromised sometime during the sample handling process, and is a (b)(6) result.

• Brand Name: GS HIV COMBO AG/AB EIA
• Common Device Name: HIV COMBO
• Manufacturer (Section D): BIO-RAD LABORATORIES; 6565 185th ave ne; redmond WA 98052
• MDR Report Key: 7504774
• Report Number: 3022521-2018-00002
• Device Sequence Number: 1225031
• Product Code: MZF
• UDI-Device Identifier: 00847865010658
• UDI-Public: 00847865010658
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: BP100064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2018

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: 09/06/2018
• Device Catalogue Number: 26217
• Device Lot Number: 159MJJ-02
• 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: 04/12/2018
• Initial Report FDA Received Date: 05/10/2018
• 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: Hospitalization