MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC PRISM 6 CHANNEL ANALYZER; AUTOMATED IMMUNOASSAY ANALYZER

Catalog Number	06A36-04
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a.Patient information: no further patient information was provided by the customer.
Event or Problem Description
The customer observed false (b)(6) prism hiv o plus results for several samples.During the week of (b)(6) 2019 39 (b)(6) results were generated.Confirmatory testing using western blot and eia confirmed 26 of the 39 samples were (b)(6).No impact to patient management was reported.
Additional Manufacturer Narrative
Abbott prism reaction trays, lot number 05076m700 was considered the likely cause.A review of complaint data for the product and likely cause lot identified normal complaint activity.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.The prism hiv o plus initial and repeat reactive rates were analyzed and the customer's reactive rates were elevated and outside of chart control limits for the week of 08sep2019.However reactive rates were close to historical levels for all subsequent weeks.Both initial reactive and repeat reactive rates for the week of 08sep2019 were below the prism hiv o plus reactive rate upper confidence intervals for plasma donors.The reactive rates for peer plasma sites were within chart control limits for the week of 08sep2019 and below the prism hiv o plus reactive rate upper confidence intervals for plasma donors.Additionally, prism hiv o plus reactive rates associated with master lot 02011n100 and both the customer's site and the peer plasma sites were within chart control limits and below the prism hiv o plus reactive rate upper confidence intervals for plasma donors.Furthermore, prism hiv o plus reactive rates obtained with prism reaction tray lot number 05076m700 were analyzed and were within chart control limits and below the prism hiv o plus reactive rate upper confidence intervals for plasma donors.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the prism reaction trays, lot number 05076m700 was identified.

• Brand Name: PRISM 6 CHANNEL ANALYZER
• Common Device Name: AUTOMATED IMMUNOASSAY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9168374
• Report Number: 1628664-2019-00659
• Device Sequence Number: 3884521
• Product Code: MZA
• UDI-Device Identifier: 00380740008420
• UDI-Public: 00380740008420
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: BK970042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2019

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 Catalogue Number: 06A36-04
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LOT 02011N100; LOT 02011N100; PRISM HIV O PLUS, LIST 03L68-68; PRISM HIV O PLUS, LIST 03L68-68