MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT ANTI-HCV

Catalog Number 06C37-32

Device Problem False Negative Result (1225)

Patient Problem Hepatitis (1897)

Event Type  Injury  

Manufacturer Narrative

This report is being filed on an international product, architect anti-hcv, list 6c37, that has a similar product distributed in the us, anti-hcv, list number 1l79.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a (b)(6) result from a blood donation from a (b)(6) year old female.The second donation from the donor generated (b)(6) results.The plasma product from the first donation was sold to a company for use in research where it was tested for (b)(6) rna pcr and generated a (b)(6) result.The customer further indicated three recipients received the blood products from the first donation.Recipient 1 ((b)(6) year old male) received the red blood cells and is being treated at the hospital (type of treatment is unknown).Recipient 1 has tested (b)(4) on the architect assay.See also manufacturer report numbers 3002809144-2018-00022 and 3002809144-2018-00023 for the 2 other recipients and 3002809144-2018-00025 for the anti-hcv assay.

Manufacturer Narrative

Further investigation of the issue included a review of the complaint text, a search for similar complaints, in-house testing, review of manufacturing documents and a review of labeling.The sample that tested non-reactive with the architect anti-hcv assay was not available for return, therefore sample specific testing could not be performed.Review of complaint activity determined that there is normal complaint activity for likely cause lot 81494li00.Tracking and trending report review for the architect anti-hcv assay determined that there are no related adverse or non-statistical trends.A retained reagent kit of lot number 81494li00 was calibrated and controls were ran.The calibration met instrument specifications and all controls were in the typical range.The reagent lot was tested in a sensitivity setup including two internal sensitivity panels and additional replicates of the positive control.The sensitivity panel values and the positive control values met specifications.The results were in the typical range and no false non-reactive results were obtained.Additionally, two commercially available seroconversion panels were tested with reagent lot 81494li00 and the results were compared to architect anti-hcv results provided by the panel manufacturer.Reagent lot 81494li00 detected the same bleeds as reactive with comparable s/co values for the seroconversion panels.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect anti-hcv assay was identified.

• Brand Name: ARCHITECT ANTI-HCV
• Type of Device: ANTI-HCV
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 7338707
• MDR Text Key: 102385369
• Report Number: 3002809144-2018-00021
• Device Sequence Number: 1
• Product Code: MZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2018
• Device Catalogue Number: 06C37-32
• Device Lot Number: 81494LI00
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/07/2018
• Initial Date FDA Received: 03/14/2018
• Supplement Dates Manufacturer Received: 04/06/2018
• Supplement Dates FDA Received: 04/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR; ARCHITECT I2000SR; LIST 03M74-01, SERIAL (B)(4); LIST 03M74-01, SERIAL (B)(4) ; ARCHITECT I2000SR; LIST 03M74-01, SERIAL (B)(4)
• Patient Outcome(s): Disability
• Patient Age: 83 YR