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

Catalog Number	07026773190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem 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.
Additional 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
• Common Device Name: HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12519814
• Report Number: 1823260-2021-02794
• Device Sequence Number: 17127936
• Product Code: LOL
• UDI-Device Identifier: 04015630939855
• UDI-Public: 04015630939855
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K093955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 07026773190
• Device Lot Number: 525231
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/06/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1