MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT ANTI-HCV

Catalog Number	01L79-25
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ticket searches determined that there is a normal complaint activity for reagent lot 59770li00.The 12 month tracking and trending report review determined that there are no adverse trends and no non-statistical trends for the complaint issue.No non-conformances or deviations were identified.Analytical sensitivity was tested using an in-house retained reagent kit of lot 59770li00.All specifications were met with no false non-reactive results generated.Clinical sensitivity was also evaluated by testing two commercially available seroconversion panels.All specifications passed verifying that the sensitivity performance of the lot is not adversely affected.The architect anti-hcv assay package insert contains information to address the current customer issue.Based on the results of this evaluation and the information from the customer site, a product malfunction was identified as the device failed to meet performance specifications or otherwise perform as intended at the customer site.However, no systemic issue or product deficiency was identified.
Event or Problem Description
The customer reports that the positive control for the architect anti-hcv assay is reading negative on one of the architect i1000sr analyzers in the lab.Controls were within specifications at the beginning of the day.The reagent pack in use at that time ran out of reagent and the analyzer switched over to a new reagent pack of the same lot.Controls were not run again until the following day at which time the out of specification issue was found.There are no issues with any other analyzer in the lab or with any other assays on this particular architect i1000sr analyzer.Customer support recommended several trouble shooting procedures, which the customer performed.Afterwards, four previous samples tested six days earlier were pulled for retesting, two of which were positive and two negative.The two negative samples remained negative; however, one of the previous positive samples (5.83 s/co) now read negative (0.65 s/co).This patient is known to be anti-hcv reactive.The other positive sample (12.77 s/co) remained positive but now read at 1.98 s/co.This patient is also known to be anti-hcv reactive.Customer support suggested further troubleshooting procedures to try.The customer then retested 56 patient samples using a fresh reagent pack of this same lot of reagent (59770li00) and found one sample that had originally tested non-reactive now testing reactive (no specific patient results or information provided).An amended report was supplied to the appropriate clinician.There is no reported impact to patient care due to this issue.

• Brand Name: ARCHITECT ANTI-HCV
• Common Device Name: ANTI-HCV
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 6577049
• Report Number: 3002809144-2017-00068
• Device Sequence Number: 1169938
• Product Code: MZO
• UDI-Device Identifier: 00380740001414
• UDI-Public: (01)00380740001414(17)161024(10)59770LI00
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 05/18/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2016
• Device Catalogue Number: 01L79-25
• Device Lot Number: 59770LI00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2017
• Initial Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I1000SR ANALYZER; LN: 01L86-01 SN: (B)(4)