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 06/28/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The c502 module serial number was (b)(4).The c701 module serial number was (b)(4).Calibration and qc data were acceptable.

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for creatinine plus ver.2 (crep2) on a cobas 8000 c 502 module and a cobas 8000 c 701 module compared to the creatinine jaffe method at a different hospital.The initial crep2 result from the c 502 module was 301 umol/l.This result was reported outside of the laboratory.On (b)(6) 2019 a new sample was obtained and the crep2 result from the c701 module was 94 umol/l.Since the initial result was high, the patient was sent to the hospital for confirmation testing.The high creatinine result was not reproduced.The actual result received was not provided.On (b)(6) 2019 the customer repeated the initial sample on the c701 module and got a crep2 result of 305 umol/l.The customer sent the sample to an external laboratory where the result using the creatinine jaffe method was 134 umol/l.On (b)(6) 2019 the customer repeated both samples from the patient and got crep2 results of 133 umol/l and 74 umol/l on the c502 module and crep2 results of 130 umol/l and 73 umol/l on the c 701 module.The patient was taking "mtx" medication.This was stopped 3 weeks prior to the event.There was no allegation that an adverse event occurred.

Manufacturer Narrative

Relevant tests/laboratory data was updated.A reagent issue is not suspected as calibration and qc data were acceptable.The malfunction is consistent with an issue with the patient sample or pre-analytics.The customer has had no further issues.The investigation did not identify a product problem.The cause of the event could not be determined.- attachment: [additionaltestsq-277904.Pdf].

• Brand Name: CREATININE PLUS VER.2
• Type of Device: ENZYMATIC METHOD, CREATININE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8830971
• MDR Text Key: 152673565
• Report Number: 1823260-2019-02716
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• PMA/PMN Number: K024098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/03/2019

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 Model Number: CREP G2
• Device Catalogue Number: 05168589190
• Device Lot Number: 409005
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 07/26/2019
• Supplement Dates Manufacturer Received: 07/04/2019
• Supplement Dates FDA Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALUPURINOL; RAMIPRIL
• Patient Age: 58 YR