MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HAV IGM; HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)

Catalog Number 07026773190

Device Problem False Positive Result (1227)

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

Event Date 09/02/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

There was an allegation of a questionable false-positive anti-hav igm elecsys result from cobas e 801 analytical unit serial number (b)(4).The initial result was 1.78 coi (positive).The repeat result was 1.75 coi (positive).The repeat result after centrifugation with a high-speed centrifuge was 1.71 coi (positive).The result from a siemens analyzer was 0.10 coi (negative).The questionable results were not reported outside of the laboratory.

Manufacturer Narrative

No sample material was available, therefore no further investigation was possible.The investigation did not identify a product problem.  the cause of the event could not be determined.  based on calibration and qc results, a general reagent issue could be excluded.

• Brand Name: ELECSYS ANTI-HAV IGM
• Type of Device: HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12519814
• MDR Text Key: 272942344
• Report Number: 1823260-2021-02794
• Device Sequence Number: 1
• Product Code: LOL
• UDI-Device Identifier: 04015630939855
• UDI-Public: 04015630939855
• Combination Product (y/n): N
• PMA/PMN Number: K093955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

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: 10/31/2021
• Device Catalogue Number: 07026773190
• Device Lot Number: 525231
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/06/2021
• Initial Date FDA Received: 09/23/2021
• Supplement Dates Manufacturer Received: 09/28/2021
• Supplement Dates FDA Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1