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U.S. Department of Health and Human Services

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

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ROCHE DIAGNOSTICS CREATININE PLUS; ENZYMATIC METHOD, CREATININE Back to Search Results
Catalog Number 11775685216
Device Problem High Test Results (2457)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 01/22/2014
Event Type  malfunction  
Manufacturer Narrative
The customer provided additional information.Date of event was (b)(6) 2014.There were no adverse events.The customer has stated the initial crep result was 112 umol/l, not 113 umol/l.Clarification has been requested but not provided.The customer has stated the repeat crep result was 84 umol/l, not 80 umol/l, and the result of 84 umol/l was reported outside the laboratory.Clarification has been requested but not provided.The customer also stated the patient's sample was repeated twice and another sample was tested and the result of 84 umol/l was confirmed.The crep r1 reagent lot number was 687257-01.The crep r2 reagent lot number was 684128-01.The field service representative went on site.At that time, the customer stated they were having issues with "creatinine fliers" but did not provide any information about patient samples involved.The field service representative adjusted wash levels, replaced the r1 reagent probe, and checked the gear pump pressure.There have been no further complaints from the customer.A specific root cause could not be determined with the information provided.Additional details for further investigation were requested but not provided.
 
Event Description
The customer alleged they received a questionable creatinine plus (crep) result for one patient.The customer stated they repeated approximately 30 samples from the day's workload, including 4 samples run in and around the same time as the affected sample, and all the repeat results were similar to the original results.The analyzer this event occurred on was requested but not provided.The specific date of this event was requested but not provided.The patient's initial crep result was 113 umol/l and it was reported outside the laboratory.The client questioned the result and the sample was repeated.The repeat result was 80 umol/l.Information on whether the patient was adversely affected was requested but not provided.The crep reagent lot number and expiration date were requested but not provided.
 
Manufacturer Narrative
This event occurred in (b)(6).
 
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Brand Name
CREATININE PLUS
Type of Device
ENZYMATIC METHOD, CREATININE
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhoferstrasse 116
na
mannheim (baden-wurttemberg) 6830 5
GM   68305
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key3622770
MDR Text Key11552622
Report Number1823260-2014-00895
Device Sequence Number1
Product Code JFY
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K953239
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 03/19/2014
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 Number11775685216
Device Lot NumberASKU
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Event Location Laboratory
Initial Date Manufacturer Received 01/22/2014
Initial Date FDA Received02/11/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/19/2014
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 Number1
Patient Age054 YR
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