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U.S. Department of Health and Human Services

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

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ROCHE DIAGNOSTICS CREATININE PLUS VER.2; ENZYMATIC METHOD, CREATININE Back to Search Results
Catalog Number 03263991190
Device Problem High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/17/2014
Event Type  malfunction  
Event Description
The customer reported that they received erroneous results for one patient sample tested for creatinine plus ver.2 (crep).Results from 2 different c501 analyzers and a c701 analyzer were compared to results from an ortho vitros analyzer.The results from the ortho vitros method were believed to be correct.Given the discordance of the patient's normal biopsy and other normal serum chemistry analysis, the laboratory was contacted about a potential interference and found normal serum creatinine concentrations with the jaffe assay as well as the vitros enzymatic assay.The patient sample was initially tested on c701 analyzer serial number (b)(4)with an unknown reagent lot number, resulting as 2.21 mg/dl.The sample was repeated on c501 analyzer serial number (b)(4) with reagent lot 60387301 (exp: 05/31/2015) on (b)(6) 2014, resulting as 6.31 mg/dl.The 6.31 mg/dl value was reported outside of the laboratory.The sample was manually diluted times 2 and tested on c501 analyzer serial number (b)(4) on (b)(6) 2014, resulting with a raw value of 1.23 mg/dl.The 1.23 mg/dl value was multiplied by the dilution factor, resulting with an actual value of 2.46 mg/dl.The sample was manually diluted times 3 and tested on c501 analyzer serial number (b)(4) on (b)(6) 2014, resulting with a raw value of 0.28 mg/dl.The 0.28 mg/dl value was multiplied by the dilution factor, resulting with an actual value of 0.84 mg/dl.The sample was manually diluted times 3 and tested on c501 analyzer serial number (b)(4) on (b)(6) 2014, resulting with a raw value of 0.28 mg/dl.The 0.28 mg/dl value was multiplied by the dilution factor, resulting with an actual value of 0.84 mg/dl.The sample was manually diluted times 4 and tested on c501 analyzer serial number (b)(4) on (b)(6) 2014, resulting with a raw value of 0.22 mg/dl.The 0.22 mg/dl value was multiplied by the dilution factor, resulting with an actual value of 0.88 mg/dl.The sample was then tested on an ortho vitros analyzer on (b)(6) 2014, resulting as 0.93 mg/dl.The sample was repeated on the ortho vitros analyzer with an on board dilution of times 2 on (b)(6) 2015, resulting as 0.92 mg/dl.The sample was repeated on the ortho vitros analyzer with an on board dilution of times 3 on (b)(6) 2015, resulting as 0.91 mg/dl.The sample was repeated on the ortho vitros analyzer with an on board dilution of times 4 on (b)(6) 2015, resulting as 0.94 mg/dl.The patient was not adversely affected.The customer declined service as he believed the issue to be sample specific.
 
Manufacturer Narrative
It was unknown if the initial reporter sent a report to the fda.
 
Manufacturer Narrative
A specific root cause could not be determined based on the provided information.Additional information required for investigation was requested, but not provided.A specific analyzer or reagent issue can be excluded since calibration and controls were fine.It is assumed that the involved patient sample turbidity can be explained to be a result of gammopathy.The patient was said to have a history of "monoclonal gammopathy of undetermined significance".This interference is covered in product labeling.
 
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Brand Name
CREATININE PLUS VER.2
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 Key4521534
MDR Text Key5407260
Report Number1823260-2015-01213
Device Sequence Number1
Product Code JFY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K024098
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 03/23/2015
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 Number03263991190
Device Lot NumberASKU
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Event Location Laboratory
Initial Date Manufacturer Received 02/04/2015
Initial Date FDA Received02/17/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/23/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
LISINOPRIL-HCTZ (1 TABLET DAILY); CALCIUM CARBONATE (1 TABLET DAILY); OMEGA 3 FISH OIL (1 CAPSULE DAILY); TEARS NATURALE (1 DROP OPHTHALMIC AS NEEDED); CENTRUM SILVER (1 TABLET DAILY); OCUVITE (1 TABLET DAILY)
Patient Age085 YR
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