MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT ANTI-HCV

Catalog Number 06C37-78

Device Problem False Positive Result (1227)

Patient Problem Misdiagnosis (2159)

Event Date 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A clinician questioned repeat (b)(6) architect anti-hcv results generated for a (b)(6) year old male dailysis patient on (b)(6) 2019 and (b)(6) 2019.Based on the (b)(6) results, the clinician assigned the patient to the (b)(6) patient group and performed dialysis.Elisa anti-hcv and (b)(6) rna testing was (b)(6), so the clinician suspected the architect results to be (b)(6).The patient was tested again on (b)(6) 2019 and the anti-hcv result was (b)(6).The patient was exposed to (b)(6) dialysis equipment.No post-dialysis (b)(6) testing was provided.Since it is unknown when the last exposure to the (b)(6) dialysis equipment was, it cannot be ruled out that an adverse event / serious injury may have occurred.

Manufacturer Narrative

Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Historical lot specific search could not be performed since the lot number used by the customer is unknown.Field data was used to evaluate the number of standard deviations to the cut-off for the negative population tested with the architect anti-hcv assay.The number of standard deviations to the cutoff for the negative population tested are within the established limits or above which is even a better performance.The initial reactive rate by time was reviewed for the last 6 months.The initial reactive rate was within established limits or below the limit.A review of labeling concluded that the issue is sufficiently addressed in the labeling.Based on the available information, no product deficiency 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: 8823603
• MDR Text Key: 152936181
• Report Number: 3002809144-2019-00467
• 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: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 06C37-78
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LIST 03M74-02, SERIAL (B)(4); LIST 03M74-02, SERIAL (B)(4)
• Patient Outcome(s): Other
• Patient Age: 59 YR