MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT ANTI-HCV

Catalog Number 06C37-74

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier = (b)(6).This report is being filed on an international product, list number 6c37 that has a similar product distributed in the us, list number 1l79.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided by the customer.

Event Description

The customer reported false nonreactive architect anti-hcv results on a (b)(6) pregnant patient.The patient was waiting for surgery in the emergency department.The patient sample was drawn on (b)(6) 2020, however, since the anti-hcv assay was not calibrated on the architect, the sample was not tested until (b)(6) 2020.The results provided were: on (b)(6) 2020 the maccura instrument = (b)(6); on (b)(6) 2020 (b)(6) architect = (b)(6).There were no other tests performed to determine which result was correct.The patient had delayed surgery (unknown what type) while waiting for the architect results.There was no actual adverse impact to the patient reported.

Manufacturer Narrative

Correction to section d suspect medical device, 4.Catalog # from 06c37-27 to correct 06c37-74, lot # from 11370be00 to correct 11370be03, and udi from (b)(4).

Manufacturer Narrative

The complaint investigation for fa alse non-reactive result for one patient tested with the architect anti-hcv assay included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review and inhouse testing of retained kits of lot 11370be00.Lots 11370be00 and 11370be03 contain the same bulk material and are identical except the labeling of the outer package.Return testing was not completed as returns were not available.Trending review determined no trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with the lot and complaint issue.A review of the product labeling concluded that the issue is sufficiently addressed.In house testing of two commercially available seroconversion panels (zeptometrix hcv 9047 and hcv 9045) was performed with the lot.The seroconversion panel results were compared to historical architect hcv test results provided by zeptometrix.The reagent detected the same bleeds as reactive with comparable s/co values for the seroconversion panels.Based on these data, it was shown that the sensitivity performance of the lot is not negatively affected.Based on the investigation, no systemic issue or deficiency with the architect anti-hcv reagent, lot 11370be03 was identified.

• Brand Name: ARCHITECT ANTI-HCV
• Type of Device: ANTI-HCV
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10326243
• MDR Text Key: 222162358
• Report Number: 3002809144-2020-00732
• 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,Followup
• Report Date: 09/09/2020

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: 09/10/2020
• Device Catalogue Number: 06C37-74
• Device Lot Number: 11370BE03
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/27/2020
• Supplement Dates Manufacturer Received: 08/11/2020; 09/09/2020
• Supplement Dates FDA Received: 08/31/2020; 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LN 03M74-01,; ARCHITECT I2000SR ANALYZER, LN 03M74-01,; ARCHITECT I2000SR ANALYZER, LN 03M74-01,; SERIAL # (B)(6) ; SERIAL # (B)(6) ; SERIAL # (B)(6)
• Patient Age: 29 YR