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

Catalog Number 05168589190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

The customer received questionable low creatinine plus ver.2 results for several patient samples after getting abnormal probe sucking alarms from cobas c702 analyzer serial number (b)(4).The customer performed a sample probe wash and stated he would take a stylus to the sample probe to remove any clots.After changing the sample probes, the customer stated about 70% of the qc was out of range.He noted the rinse mechanism appeared to be ok but the probes appear to be misaligned.When the customer began seeing very low results, he stopped running patient samples and repeated testing on another analyzer.Of the data provided, only the results for one patient sample were discrepant and reported outside the laboratory.The initial result was 0.1 mg/dl and was automatically verified.The corrected result was 1.1 mg/dl.Information was provided that four other patient results were reported outside the laboratory and corrected results were called.No specific data for these patients could be provided.There was no adverse event.The field service representative found the reagent was contaminated.After replacing four of the affected reagents one assay at a time, qc values returned to expected limits.

Manufacturer Narrative

Based on the provided information, further investigation could not determine a specific root cause.No failure in the performance of the system was verified.The root cause was most likely either contamination or deterioration of the reagent.Since no damage or misalignment of any of the probes was found during the service visit, it was suspected the contamination occurred before the reagents were placed on the instrument.

• 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: 5786059
• MDR Text Key: 49393260
• Report Number: 1823260-2016-00893
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05168589190
• Device Lot Number: ASKU
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2016
• 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