MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALBUMIN GEN.2; BROMCRESOL GREEN DYE-BINDING, ALBUMIN

Catalog Number 05166861190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received questionable alb2 albumin gen.2 results for multiple patient samples from cobas 8000 c 702 module serial number (b)(4).The customer performs qc every four hours and if the results are out of range, they repeat patient samples.Of the data provided, only the results for one sample were discrepant.The initial result was 1.9 g/l and the repeat result was 2.5 g/l.The erroneous result was reported outside of the laboratory.The repeat result was believed to be correct.The patient was not adversely affected.The customer believed the issue occurred when the reagent pack volume was low.After evaluation of the provided calibration and qc data, a general reagent issue cannot be identified.

Manufacturer Narrative

The field service representative checked the instrument and found no issues.The investigation was unable to find a definitive root cause.A general reagent or hardware issue was excluded.

• Brand Name: ALBUMIN GEN.2
• Type of Device: BROMCRESOL GREEN DYE-BINDING, ALBUMIN
• 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: 7233467
• MDR Text Key: 99004491
• Report Number: 1823260-2018-00290
• Device Sequence Number: 1
• Product Code: CIX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05166861190
• Device Lot Number: 262685
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2018
• 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
• Patient Age: 70 YR