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

Catalog Number 07026773190

Device Problem Patient Data Problem (3197)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined the application file created for the (b)(6) igm instrument settings was incorrect. The application file was assigned cutoff ranges for the(b)(6) igm reagent used outside of the united states. In the settings used in the rest of the world, there is no borderline cutoff range for the (b)(6) igm assay. Values with a coi of < 1. 0 are "non reactive" and values with a coi >
=
1. 0 are "reactive".

Event Description

The initial reporter stated they received questionable results for an unspecified number of patient samples tested with elecsys (b)(6) igm on a cobas 8000 e 801 module. The result interpretation assigned to these samples from the analyzer software did not appear to be correct as the interpretation did not agree with the cutoff values documented in product labeling. The customer provided examples of (b)(6)igm results from two pooled patient samples and the result interpretation for these samples were discrepant. No incorrect results were reported outside of the laboratory as the customer was using pooled samples to validate the system software. The first sample resulted with an (b)(6) igm value of 0. 926 coi. The analyzer software assigned a result interpretation of "non reactive". Based on product labeling, the interpretation for this value should be "borderline" as the cutoff values for "borderline" are >
=
0. 90 coi and < 1. 10 coi. The second sample resulted with an (b)(6) igm value of 1. 02 coi. The analyzer software assigned a result interpretation of "reactive". Based on product labeling, the interpretation for this value should be "borderline" as the cutoff values for "borderline" are >
=
0. 90 coi and < 1. 10 coi. The e 801 analyzer serial number is (b)(4).

• 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: 9238887
• MDR Text Key: 219582755
• Report Number: 1823260-2019-03859
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 07026773190
• Device Lot Number: 435246
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/02/2019
• 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

Type of Device Usage

• Removal/Correction Number: RES81823