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 Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/11/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed discrepant alinity s anti-hcv results for a patient/donor sample when repeat testing of the sample was performed due to the original release control failures that were generated on multiple reagent cartridges of the alinity s anti-hcv assay.The following results were provided (reference range: < 1.00 s/co is nonreactive, >/= 1.00 s/co is reactive): initial result = (b)(6) with reagent cartridge sn# (b)(6), repeated using different cartridge sn# (b)(6) = (b)(6), roche nat = (b)(6), ortho elisa hcv = initial (b)(6) and final result = nonreactive.It is unclear which results are correct.There was no impact to patient management reported.

Event Description

The customer observed false reactive alinity s anti-hcv results for a patient/donor sample when repeat testing of the samples were performed due to the original release control failures that were generated on multiple reagent cartridges of the alinity s anti- hcv assay.The following results were provided (reference range: < 1.00 s/co is nonreactive, >/= 1.00 s/co is reactive): initial result = 1.72 s/co, repeated on another analyzer = 0.73, 0.68 s/co with reagent cartridge sn#(b)(6), repeated using a third cartridge sn#(b)(6) = 1.64, 1.72 s/co, roche nat testing = negative, ortho elisa hcv = nonreactive.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for falsely reactive results for one donor sample while using alinity s anti-hcv assay included a search for similar complaints, and the review of complaint text, trending data, labeling, field data analysis, and device history records.Return testing was not performed as returns were not available.Evaluation of complaint data for the product and likely cause lot identified normal complaint activity.The ticket trending review determined that there are no trends identified for the product for the issue.The device history records review determined no non-conformances or deviations were identified.Analysis of the field data review was performed.Review of all available customer performance data indicates that the reagent lot identified in the complaint is within product requirements when assessed across all us customer testing (regardless of peers) as well as within the us whole blood peer group (including bloodworks northwest (bwnw)).Additionally, aggregated performance of lot 26209be00 across all us customers is comparable to the performance of all lots of the same assay evaluated in the comparison.Focusing on the us whole blood rr performance, the performance of the complaint lot at bwnw was comparable to the performance of the same lot at the peer sites (excluding bwnw) and within product requirements.The overall % specificity assuming 0 prevalence for each of the master lots for the customer of interest was comparable to their peer group.Review of available customer testing data for the us whole blood peers indicated that the performance of the instruments at the customer of interest over time was within the performance exhibited by their peer group and did not exhibit a time-based performance difference for the assay.Repeat reactive rate (rrr) and %specificity (assuming 0 prevalence) was calculated for lot number 26209be00 for all customers using this lot and us peers including and excluding bwnw as well at bwnw.All customers: 99.925% specificity; 0.075% (rrr) us peers including bwnw: 99.889% specificity; 0.111% (rrr) us peers excluding bwnw: 99.881% specificity; 0.119% (rrr) bloodworks northwest (usa): 99.954% specificity; 0.046% (rrr) a review of labeling concluded that the issue is sufficiently addressed.Based on the investigation alinity s anti-hcv reagent lot 26209be00 is performing as intended, no systemic issue or product deficiency of the alinity s anti-hcv reagent was identified.B5 - describe event or problem initial: the customer observed discrepant alinity s anti-hcv results for a patient/donor sample when repeat testing of the sample was performed due to the original release control failures that were generated on multiple reagent cartridges of the alinity s anti-hcv assay.The following results were provided (reference range: < 1.00 s/co is nonreactive, >/= 1.00 s/co is reactive): initial result = 1.72 s/co, repeated on another analyzer = 0.73, 0.68 s/co with reagent cartridge sn#(b)(6), repeated using different cartridge sn#(b)(6) = 1.64, 1.72 s/co, roche nat = negative, ortho elisa hcv = initial reactive (ir) and final result = nonreactive.It is unclear which results are correct.There was no impact to patient management reported.Updated description of the event: the customer observed false reactive alinity s anti-hcv results for a patient/donor sample when repeat testing of the samples were performed due to the original release control failures that were generated on multiple reagent cartridges of the alinity s anti- hcv assay.The following results were provided (reference range: < 1.00 s/co is nonreactive, >/= 1.00 s/co is reactive): initial result = 1.72 s/co, repeated on another analyzer = 0.73, 0.68 s/co with reagent cartridge sn#3638, repeated using a third cartridge sn#191 = 1.64, 1.72 s/co, roche nat testing = negative, ortho elisa hcv = nonreactive.There was no impact to patient management reported.H6 - adverse event problem initial medical device problem code: a0908 updated medical device problem code: a090804.

• 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
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12706725
• MDR Text Key: 279817454
• Report Number: 3002809144-2021-00620
• Device Sequence Number: 1
• Product Code: QHM
• UDI-Device Identifier: 00380740117191
• UDI-Public: 00380740117191
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 200
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2021

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: 02/11/2022
• Device Catalogue Number: 06P04-60
• Device Lot Number: 26209BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 12/10/2021
• Supplement Dates FDA Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY S SYSTEM, 06P16-01, (B)(6); ALNTY S SYSTEM, 06P16-01,(B)(6)