MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S ANTI-HCV II REAGENT KIT; HEPATITIS C VIRUS CORE (SYN PEPTIDE) AND NS3 HELICASE (E COLI, RECOMBINANT) AG

Catalog Number 04W56-55

Device Problem False Negative Result (1225)

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

Event Date 04/14/2022

Event Type  malfunction  

Event Description

The account generated a false negative alinity s anti-hcv ii result on a sample that tested alinity i anti-hcv grayzone and innolia method positive.Originally, this sample came to the account (bb ljubljana) for reference testing to confirm grayzone alinity i anti-hcv result (0.99, 0.94, 0.97 s/co) generated at another lab (bb maribor, using grayzone range of 0.9 to 1.0 s/co).The account performed alinity s anti-hcv ii and innolia method testing.The sample generated alinity s anti-hcv ii negative (0.11 s/co) result and innolia method positive (28.4, first time tested only innolia c2 unclear, ns 4 positive; second time tested 6.5 and same result).Additional sample testing generated negative hiv, syphilis, hbsag and pcr pool negative results.The customer (bb maribor) of the account (bb ljubljana) believes the innolia positive result was false positive, but because innolia method is a confirmatory method, the customer (bb maribor) treated the sample as positive.The donor blood unit was destroyed.No specific patient information provided.No impact to patient management was reported.

Manufacturer Narrative

(b)(6).This report is being filed on an international product list 4w56, that has a similar us product distributed in the us, list 6p04-60.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

Ticket searches determined that there is a normal complaint activity for the product and likely cause lot and the ticket trending review determined that there are no related adverse trends.A review of labeling concluded that the issue is sufficiently addressed.The performance of the likely cause lot was investigated by completing a review in the corrective and preventative action system for non-conformances, potential non-conformances and deviations related to the likely cause lot.The review did not identify any non-conformances, potential non-conformances or deviations.Returned sample id (b)(6) was tested in-house with inno-lia hcv score and mikrogen recomline hcv igg blots.The inno-lia hcv score blot showed a reactivity of 1+ for ns4 and a weak reactivity of +/- for c2, final interpretation per package insert is reactive.The mikrogen recomline hcv blot showed weak reactivity of +/- for c1, helicase and ns4, final interpretation per package insert is negative.The external laboratory testing resulted negative per the roche elecsys anti-hcv ii package insert.Per abbott medical evaluation, the nonreactive results with alinity s anti-hcv ii and alinity i anti-hcv, the nonreactive result with roche elecsys anti-hcv ii, the negative mikrogen blot result, and the reactive inno-lia blot results, indicate the hcv status of the sample is not false negative.We conclude that this sample does not contain hcv specific antibodies.The sample in question may contain antibodies that are cross reacting with the hcv ns4 antigen but are not true hcv specific antibodies.Therefore, the alinity s anti-hcv ii result is not false-negative.Based on this investigation, the complaint likely cause is performing as expected.Based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site as it was concluded that this sample does not contain hcv specific antibodies.A systemic issue and/or product deficiency was not identified.

• Brand Name: ALINITY S ANTI-HCV II REAGENT KIT
• Type of Device: HEPATITIS C VIRUS CORE (SYN PEPTIDE) AND NS3 HELICASE (E COLI, RECOMBINANT) AG
• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15053535
• MDR Text Key: 304800584
• Report Number: 3002809144-2022-00249
• Device Sequence Number: 1
• Product Code: QHM
• Combination Product (y/n): N
• Reporter Country Code: SI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

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: 08/22/2022
• Device Catalogue Number: 04W56-55
• Device Lot Number: 36012BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 08/12/2022
• Supplement Dates FDA Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2022
• 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, AS1164; ALNTY S SYSTEM, 06P16-01, AS1164