MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HIV COMBI PT; HIV DETECTION TEST

Model Number HIV COMBI

Device Problems Illegible Information (4050); Wrong Label (4073)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2022

Event Type  malfunction  

Event Description

The initial reporter complained of a labeling issue with one reagent kit for elecsys hiv combi (hiv combi).When the customer scanned the barcode label from the reagent, the reagent was not identified.The customer made repeated attempts to rescan the barcode label and eventually the instrument software identified the reagent as elecsys ca 15-3.Other reagent kits for hiv combi were identified correctly and are currently being used for patient testing.The e602 module serial number is (b)(4).

Manufacturer Narrative

The affected reagent kit was requested for investigation.The reagent kit (including the pre-treatment and reagent) was received for investigation.A visual check of the barcode labels shows that the diamond and the id number of the labels are printed black and both the pre-treatment and reagent labels were smeared.The filling volume was checked.The investigation is ongoing.

Manufacturer Narrative

The barcode labels were investigated further and were determined to be counterfeit: -the original roche labels on the reagents show a colored warning sign (diamond printed in red) whereas the label of the kit complained does show a black printed diamond.-the nature of the material ("paper") looks different.-the plain text has no clarity.-the label quality.It could not be determined who produced the labels or where they were produced.The labels were non-roche labels.

• Brand Name: ELECSYS HIV COMBI PT
• Type of Device: HIV DETECTION TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15914807
• MDR Text Key: 308168836
• Report Number: 1823260-2022-03852
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: BP160050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

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: 01/31/2023
• Device Model Number: HIV COMBI
• Device Catalogue Number: 05390095190
• Device Lot Number: 596423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 12/19/2022
• Supplement Dates FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1