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

Catalog Number 07026773190

Device Problem False Negative Result (1225)

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

Event Date 10/08/2021

Event Type  malfunction  

Manufacturer Narrative

The sample from patient 1 is no longer available for investigation.The sample from patient 2 has been requested for investigation.From the available data, an early phase of infection has been monitored.The investigation is ongoing.

Event Description

There was an allegation of potentially (b)(6) results for two patients tested on a cobas e 801 analytical unit with serial (b)(4).The initial reporter expressed concern regarding (b)(6) results obtained for patients with (b)(6).The questionable results were not reported outside of the laboratory and the reporter was able to provide two examples of questionable results.The specimen from patient 1 was rerun on an abbott analyzer.The specimen from patient 2 was rerun on an abbott and a siemens analyzer.Please refer to the attachment on the medwatch for all patient data.

Manufacturer Narrative

The requested sample has not been received for investigation.If the sample is received in the future, a follow-up report will be submitted.All of the results provided, including the analytes are within the expected range of an early phase of hepatitis a infection.The investigation did not identify a product problem.

• 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
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12827568
• MDR Text Key: 283313630
• Report Number: 1823260-2021-03394
• Device Sequence Number: 1
• Product Code: LOL
• UDI-Device Identifier: 04015630939855
• UDI-Public: 04015630939855
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K093955
• 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: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07026773190
• Device Lot Number: 52523100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• 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
• Patient Age: 36 YR
• Patient Sex: Male