MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HAV IGM; IMMUNOCHEMISTRY ANALYZER

Model Number E602

Device Problem Computer Software Problem (1112)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2018

Event Type  malfunction  

Event Description

The field application specialist (fas) stated that the customer complained of questionable interpretation of elecsys (b)(6) results for 1 patient sample on a cobas 8000 e 602 module (e602 b).On e602 a, the (b)(6) results were (b)(6) and were correctly interpreted as (b)(6).On e602 b, the (b)(6) result was (b)(6) and was interpreted as (b)(6).The result was reported outside of the laboratory as (b)(6).There was no adverse event.The field service engineer (fse) found that the (b)(6) application version on e 602 a was different than the one on e 602 b.The setting for "borderline" for e 602 a with (b)(6) application version (b)(6) was (b)(6).The setting for "borderline" for e 602 b with (b)(6) application version (b)(6) was (b)(6).The field application specialist (fas) reloaded the assay onto e602 a and the (b)(6) application version changed to (b)(6) and the "borderline" range updated to (b)(6).The fas repeated the sample on both e602 a and e602 b and the results were (b)(6) on both modules.The (b)(6) reagent lot number was 31805000 with an expiration date of 31-dec-2018 was used on both e 602 modules.

Manufacturer Narrative

The issue was determined to be a problem with the reagent.Medwatch section were updated.

Manufacturer Narrative

The issue was determined not to be a problem with the reagent as previously stated.An application file with incorrect borderline parameters for the assay was published.A corrected application file has since been published and customers have been notified.Medwatch field has been updated.

Manufacturer Narrative

The investigation confirmed that for the anti-hav igm application version 04.10-101 the "borderline" range is set to 1.00 - 1.00 coi in the application software.Product labeling states "border 0.90 = coi < 1.10".The investigation is ongoing.

• Brand Name: ELECSYS ANTI-HAV IGM
• Type of Device: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7942881
• MDR Text Key: 125198003
• Report Number: 1823260-2018-03461
• Device Sequence Number: 1
• Product Code: LOL
• UDI-Device Identifier: 04015630929764
• UDI-Public: 04015630929764
• Combination Product (y/n): N
• PMA/PMN Number: K093955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: E602
• Device Catalogue Number: 11820591160
• Device Lot Number: 31805000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1823260-12-18-18-007-C
• Patient Sequence Number: 1
• Patient Age: 43 YR