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

Catalog Number ASKU

Device Problem High Test Results (2457)

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

Event Date 06/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This event occurred in (b)(6).

Event Description

The customer received an unknown number of questionable creatinine plus ver.2 results from two integra 400 analyzers.Data was only provided for one patient sample tested on integra 400 plus serial number (b)(4).The initial result was 1.79 mg/dl and the repeat results were 0.93 mg/dl and 0.97 mg/dl.Information regarding if the erroneous result was reported outside the laboratory or if the patient was adversely affected was requested, but was not provided.The same patient sample was repeated for precision testing and the results were good.A specific root cause could not be determined.Based on the provided data, the investigation found the aspiration of the cholesterol reagent prior to the creatinine reagent may have affected the initial creatinine result.The customer changed the processing sequence for the assays and added an extra wash cycle for the creatinine assay.As no other issues were noted, the instrument and reagents were found to be working according specification.

• 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: 5811747
• MDR Text Key: 50080770
• Report Number: 1823260-2016-01028
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Type of Report: Initial
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: 13889701
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2016
• 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