MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATININE PLUS VER.2; ENZYMATIC METHOD, CREATININE

Catalog Number 03263991190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2015

Event Type  malfunction  

Event Description

The customer discovered questionable creatinine plus ver.2 had been generated from cobas c501 serial number (b)(4) when they performed comparison testing for a new lot of reagent.Of the data provided for five patient samples, the results for three patient samples were discrepant.Patient 1: result with original lot 617550 was 1.12 mg/dl.Result with new lot 620008 was 0.93 mg/dl.Result from cobas c311 with lot 617550 was 0.93 mg/dl.Patient 2: (birthdate (b)(6) 1946, female).Result with original lot 617550 was 1.20 mg/dl.Result with new lot 620008 was 0.98 mg/dl.Result from cobas c311 with lot 617550 was 1.02 mg/dl.Patient 3: result with original lot 617550 was 1.04 mg/dl.Result with new lot 620008 was 0.86 mg/dl.Result from cobas c311 with lot 617550 was 0.76 mg/dl.The results with the new lot of reagent and from the cobas c311 were believed to be correct.The erroneous results were reported outside of the laboratory.There was no adverse event.It was noted the most recent lot calibration for reagent lot 617550 had lower absorbance values than previous lots.

Manufacturer Narrative

The investigation determined the issue with the most recent calibration was the cause of the event.Recalibration of the assay appeared to have resolved the issue.No general reagent issue was found.

• Brand Name: CREATININE PLUS VER.2
• Type of Device: ENZYMATIC METHOD, CREATININE
• 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: 5316170
• MDR Text Key: 34082048
• Report Number: 1823260-2015-06091
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024098
• 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: 01/26/2016

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: 03263991190
• Device Lot Number: 617550
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2016
• 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: 46 YR