MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S ANTI-HBC REAGENT KIT; HEPATITIS B VIRUS CORE ANTIGEN (E COLI, RECOMBINANT)

Catalog Number	06P06-60
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Was this device serviced by a third party? no.(b)(6).Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.See cross reference mfr numbers 3002809144-2021-00180, 3002809144-2021-00181, 3002809144-2021-00182, and 3002809144-2021-00184.
Event or Problem Description
The customer observed an increase in repeat (b)(6) rates in the alinity s blood screening assays (anti-hbc, htlv i/ii, hiv ag/ab, and anti-hcv) compared to the prism blood screening assays from (b)(6) 2021 to (b)(6) 2021.The customer started reporting blood screen results on the alinity s system on (b)(6) 2021 and prior to that was using the prism system.The customer also noted several donors were repeat (b)(6) on alinity s which was inconsistent with their donor testing history as compared to (b)(6) on prism.The following data was provided for the number of false repeat (b)(6) donors on the alinity s blood screening assays compared to nonreactive results obtained on the prism during previous donations by the same donors (unit number/donor number): alinity s anti-hbc (repeat (b)(6)) = 9 units/donors: (b)(6) on (b)(6) 2021, (b)(6) on (b)(6) 2021, (b)(6) on (b)(6) 2021, (b)(6).Alinity s anti-hcv (repeat (b)(6)) = 6 units/donors: (b)(6) on (b)(6) 2021, ortho anti-hcv = was (b)(6), nat hcv = (b)(6).(b)(6) on (b)(6) 2021, ortho anti-hcv = (b)(6), nat hcv = (b)(6).(b)(6) on (b)(6) 2021, ortho anti-hcv = (b)(6), nat hcv = (b)(6).(b)(6) on (b)(6) 2021, nat hcv = (b)(6), redraw (b)(6) was initial (b)(6) and repeat (b)(6) with ortho anti-hcv and nat hcv (b)(6).(b)(6) on (b)(6) 2021, ortho anti-hcv = (b)(6), nat hcv = (b)(6).(b)(6) on (b)(6) 2021, ortho anti-hcv = (b)(6), nat hcv = (b)(6).Alinity s hiv ag/ab (repeat (b)(6)) = 2 units/donors: (b)(6) on (b)(6) 2021, gs hiv-1 western blot = (b)(6), gs hiv-1/hiv-2 plus o eia = (b)(6).(b)(6) on (b)(6) 2021, gs hiv-1 western blot = (b)(6), gs hiv-1/hiv-2 plus o eia = (b)(6).Alinity s htlv i/ii (repeat (b)(6)) = 2 units/donors: (b)(6) on (b)(6) 2021, mp htlv blot = (b)(6).(b)(6) on (b)(6) 2021 htlb repeat (b)(6), mp htlv blot = indeterminate.Overall, the customer observed a 20% increase in reactive rates since moving from the prism to the alinity s.No impact to patient management was reported.
Additional Manufacturer Narrative
H6: component code: g01003.The complaint investigation for increased reactive rates and false reactive alinity s anti-hbc results, alinity s anti-hcv results, alinity s hiv ag/ab results, and alinity s htlv i/ii results included a search for similar complaints, and the review of complaint text, trending data, labeling and device history record.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the products.Device history record reviews did not identify any non-conformances or deviations for the likely cause lots and complaint issue.Labeling was reviewed and found to adequately address the issue under review.A customer data review for alinity s hiv ag/ab combo reagent, ln 6p01-60, lot 20347be00, alinity s anti-hcv, ln 6p04-60, lots 16433be00 and 17412be00; alinity s anti-hbc, ln 6p06-60, lot 15152be00 and alinity s htlv i/ii, ln 6p07-60, lot 20428be00 at central california blood center and peer sites was performed.The data review demonstrated reactive rate impact before and after the instrument maintenance the week of 2/15/2021 was assay-dependent; with improved initial and repeat reactive rates observed for anti-hbc and anti-hcv.The initial reactive rates (irr) and repeat reactive rates (rrr) for all assays at central california blood center are comparable to those of the peer sites.Further, the overall initial reactive rate, repeat reactive rate and the specificity based on zero prevalence obtained for lot numbers 15152be00, 16433be00, 17412be00, 19166fn00, 20347be00, and 20428be00 across central california blood center and peer sites are within product requirements.Based on the investigation alinity s anti-hbc reagent lot 15152be00, alinity s anti-hcv reagent lots 16433be00 and 17412be00, alinity s hiv ag/ab reagent lot 20347be00, and alinity s htlv i/ii reagent lot 20428be00 is performing as intended, no systemic issue or deficiency of the alinity s anti-hbc, alinity s anti-hcv, alinity s hiv ag/ab, and alinity s htlv i/ii reagents were identified.
Additional Manufacturer Narrative
This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.

• Brand Name: ALINITY S ANTI-HBC REAGENT KIT
• Common Device Name: HEPATITIS B VIRUS CORE ANTIGEN (E COLI, RECOMBINANT)
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11526799
• Report Number: 3002809144-2021-00183
• Device Sequence Number: 3815027
• Product Code: QHM
• UDI-Device Identifier: 00380740117207
• UDI-Public: 00380740117207
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2021

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: 03/26/2021
• Device Catalogue Number: 06P06-60
• Device Lot Number: 15152BE00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 04/28/2021; 06/08/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 04/29/2021; 06/10/2021
• 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: ALNTY S ANTI-HCV RGT, 06P04-60, 16433BE00.; ALNTY S ANTI-HCV RGT, 06P04-60, 16433BE00.; ALNTY S ANTI-HCV RGT, 06P04-60, 16433BE00.; ALNTY S ANTI-HCV RGT, 06P04-60, 17412BE00.; ALNTY S ANTI-HCV RGT, 06P04-60, 17412BE00.; ALNTY S ANTI-HCV RGT, 06P04-60, 17412BE00.; ALNTY S HIV COMBO RGT, 06P01-60, 20347BE00.; ALNTY S HIV COMBO RGT, 06P01-60, 20347BE00.; ALNTY S HIV COMBO RGT, 06P01-60, 20347BE00.; ALNTY S HTLV I/II 5000T, 06P07-60, 20428BE00.; ALNTY S HTLV I/II 5000T, 06P07-60, 20428BE00.; ALNTY S HTLV I/II 5000T, 06P07-60, 20428BE00.; ALNTY S SYSTEM, 06P16-01, AS1259.; ALNTY S SYSTEM, 06P16-01, AS1259.; ALNTY S SYSTEM, 06P16-01, AS1259.