MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S ANTI-HCV REAGENT KIT; HEPATITIS C VIRUS ENCODED ANTIGENS (RECOMBINANT C100-3, HCR43)

Catalog Number 06P04-60

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Was this device serviced by a third party? no.Completed information patient identifier: (b)(6).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.Note: see cross reference mfr numbers 3002809144-2021-00180, 3002809144-2021-00181, 3002809144-2021-00183, and 3002809144-2021-00184.

Event Description

The customer observed an increase in (b)(6) in the alinity s blood screening assays ((b)(6)) compared to the prism blood screening assays from (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 (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 (b)(6) donors on the alinity s blood screening assays compared to (b)(6) results obtained on the prism during previous donations by the same donors (unit number/donor number): alinity s ((b)(6)) = 9 units/donors: (b)(6).Alinity s ((b)(6)) = 6 units/donors: (b)(6).Alinity s ((b)(6)) = 2 units/donors: (b)(6).Alinity s ((b)(6)) = 2 units/donors: (b)(6).Overall, the customer observed a (b)(6) since moving from the prism to the alinity s.No impact to patient management was reported.Note: this emdr is for the alinity s (b)(6) on lot 17412be00.

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.

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-HCV REAGENT KIT
• Type of Device: HEPATITIS C VIRUS ENCODED ANTIGENS (RECOMBINANT C100-3, HCR43)
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11526623
• MDR Text Key: 266287290
• Report Number: 3002809144-2021-00182
• Device Sequence Number: 1
• Product Code: MZO
• UDI-Device Identifier: 00380740117191
• UDI-Public: 00380740117191
• Combination Product (y/n): N
• PMA/PMN Number: QHM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2021
• Device Catalogue Number: 06P04-60
• Device Lot Number: 17412BE00
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/19/2021
• Supplement Dates Manufacturer Received: 04/28/2021; 06/08/2021
• Supplement Dates FDA Received: 04/29/2021; 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY S ANTI-HBC 2500T, 06P06-60, 15152BE00; ALNTY S ANTI-HBC 2500T, 06P06-60, 15152BE00; ALNTY S ANTI-HBC 2500T, 06P06-60, 15152BE00; 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 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