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

Model Number CREP G2

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated that they received an erroneous result for one patient sample tested with crep2 creatinine plus ver.2 on a cobas integra 400 plus.The erroneous result was not reported outside of the laboratory.The sample initially resulted with a crep2 value of 15.29 mg/dl.The sample was repeated twice, each time resulting with a value of 0.78 mg/dl.No adverse events were alleged to have occurred with the patient.The serial number of the integra 400 plus analyzer is (b)(4).The last calibration performed on 25-dec-2018 was ok.Quality controls between 08-mar-2019 to (b)(6) 2019 were within range, except for one level of control being outside of range on the date of the event.Upon review of the alarm trace, a message indicating no fluid detected occurred on (b)(6) 2019 and a message indicating missing system reagent occurred on (b)(6) 2019.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: 8463627
• MDR Text Key: 140297043
• Report Number: 1823260-2019-01247
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CREP G2
• Device Catalogue Number: 03263991190
• Device Lot Number: 3811880
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2019
• 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
• Patient Age: 32 YR