MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT ANTI-HCV

Catalog Number 06C37-27

Device Problem Incorrect Measurement (1383)

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

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information: no further patient information was provided by the customer.All available patient information has been included.No additional patient information is available.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.

Event Description

The customer observed discrepant architect anti-hcv results on one patient.The results provided were: on (b)(6) 2020 sid (b)(6) initial (b)(6) results=(b)(6) / repeated result=(b)(6)/ repeated=(b)(6)/ repeated again=(b)(6) / after troubleshooting result=(b)(6).There was no reported impact to patient management.

Event Description

On (b)(6) 2020, the customer provided new information that the initial information provided was incorrect.The customer did not generate a false nonreactive architect anti-hcv.The correct information is the account generated a false reactive architect anti-hcv result.Based upon this new information, this complaint is no longer needed further follow up mdr will be provided.No impact to patient management was reported.

Manufacturer Narrative

Updated b5: on 28aug2020, the customer provided new information that the initial information provided was incorrect.The customer did not generate a false nonreactive architect anti-hcv.The correct information is the account generated a false reactive architect anti-hcv.Based upon this new information, this complaint is no longer needed further follow up mdr will be provided.D4: updated lot number to 13245be00 from 13378fn00.

• 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: 10364580
• MDR Text Key: 203483667
• Report Number: 3002809144-2020-00776
• 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: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2020
• Device Catalogue Number: 06C37-27
• Device Lot Number: 13245BE00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2020
• 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)(6); LIST # 03M74-02, SERIAL # (B)(6)