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

Catalog Number ASKU

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer questioned results for 1 patient tested for crep2 creatinine plus ver.2 (crep2) on a cobas 8000 c (701) module.The patient was initially drawn on (b)(6) 2018 and 2 sample tubes obtained.The initial crep2 result from 1 sample tube was 80 umol/l.This result was reported outside of the laboratory.On (b)(6) 2018 a new sample was drawn and 2 sample tubes were obtained.One tube was tested with a crep2 result of 51 umol/l.This result was reported outside of the laboratory.On (b)(6) 2018 the customer repeated both sample tubes from (b)(6) 2018 and the results were both 80.5 umol/l.The customer then repeated both sample tubes from (b)(6) 2018 and the results were both 51.0 umol/l.Based on the patient's history, the results of 51 umol/l were believed to be correct.There was no allegation that an adverse event occurred.The c701 module serial number was (b)(4).It was noted that the patient is taking hydroxychloroquine.The patient is taking it twice daily by mouth, once in the morning and once in the evening.Hydroxychloroquine has peak blood levels within 1-2 hours of ingestion.The sample tubes from (b)(6) 2018 were obtained at 12:59 p.M.This would have been after the medication dose.The sample tubes from (b)(6) 2018 were obtained at 7:21 a.M.Which may have been prior to the medication dose.The customer is not having issues with crep2 results for other patients.

Manufacturer Narrative

Crep2 calibration and qc data appear acceptable.A reagent or a hardware malfunction is excluded based on the calibration and qc data.The investigation did 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
• MDR Report Key: 7933452
• MDR Text Key: 122634906
• Report Number: 1823260-2018-03410
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 04015630924998
• UDI-Public: 04015630924998
• 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: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• 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: 351812
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HYDROXYCHLOROQUINE - 2X A DAY; HYDROXYCHLOROQUINE - 2X A DAY
• Patient Age: 66 YR