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

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.

• 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 Key: 4521534
• MDR Text Key: 5407260
• Report Number: 1823260-2015-01213
• 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 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

• Date FDA Received: 02/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03263991190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 02/04/2015
• 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 Number: 1
• 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 Age: 085 YR