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

Model Number CREP G2

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problems Unspecified Kidney or Urinary Problem (4503); Insufficient Information (4580)

Event Date 03/05/2021

Event Type  Injury  

Manufacturer Narrative

Unique identifier (udi) # (b)(4).The country of origin is (b)(6).The investigation is ongoing.

Event Description

The initial reporter alleged that "wrong" creatinine plus ver.2 results run on a cobas 8000 c (701) module analyzer serial number (b)(4) led to a kidney biopsy for two young patients.Further information about the affected patients, including medical history, specific results, other diagnostic tests that were performed, was requested but has not yet been provided at this time.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

No further information was provided.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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: 11592419
• MDR Text Key: 243286988
• Report Number: 1823260-2021-00971
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CREP G2
• Device Catalogue Number: 05168589190
• Device Lot Number: 499631
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2021
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other