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

Model Number C701

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

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Event Description

The customer received a questionable low crep2 creatinine plus ver.2 result for one patient.The initial result was 57.5 umol/l from both serum and plasma samples.On a siemens analyzer, the result was 187.23 umol/l from the plasma sample and 190.02 umol/l from the serum sample.On a beckman analyzer, the result was 164 umol/l from the plasma sample and 169 umol/l from the serum sample.The erroneous result was reported outside of the laboratory.There was no allegation of an adverse event.The reagent lot number was 283369.The expiration date was requested but as not provided.

Manufacturer Narrative

Additional information was provided that the patient has a gammopathy.Product labeling for the assay documents this interference.As the reaction kinetics for the erroneous results were not available, this interference could not be confirmed to be the root cause.

Manufacturer Narrative

Two samples (serum and plasma) were received for investigation and tested on a cobas 8000 c 702 module for both crej2 creatinine jaffé gen.2 and crep2 creatinine plus ver.2.The creatinine results for both samples and both methods were similar.Based on these results, the customer results were confirmed.All results for igg were within the normal range, the results for iga were slightly above the reference range, and the result of igm was increased.Due to the high concentration of immunoglobulin, possible igm interference exists.The investigation was unable to find a definitive root cause.As calibration and qc results were acceptable, a general reagent issue could be excluded.

• 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: 7086082
• MDR Text Key: 95071163
• Report Number: 1823260-2017-02852
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K024098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C701
• Device Catalogue Number: 05168589190
• Device Lot Number: 283369
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2017
• 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