MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ANTI-HAV; HEPATITIS A TEST

Catalog Number 04854977190

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(4).

Event Description

The customer questioned results for 1 patient sample tested for elecsys (b)(6) ((b)(6)) on a cobas 6000 e 601 module.The initial result was 56.6 iu/l.The sample was diluted x2 and the result was 113.36 iu/l.The customer suspected an igm interference as the results had poor linear dilution.It is not known if incorrect results were reported outside of the laboratory.The e601 module serial number was not provided.The customer used negative serum as a diluent instead of the specified anti-hav dilution of diluent hepatitis a.The investigation was unable to determine a definitive root cause.

• Brand Name: ANTI-HAV
• Type of Device: HEPATITIS A TEST
• 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: 7677940
• MDR Text Key: 113758683
• Report Number: 1823260-2018-02222
• Device Sequence Number: 1
• Product Code: LOL
• UDI-Device Identifier: 04015630922444
• UDI-Public: 4015630922444
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100903
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/11/2018

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 Catalogue Number: 04854977190
• Device Lot Number: 283241
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2018
• Initial Date FDA Received: 07/11/2018
• 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: N
• Patient Sequence Number: 1