MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREA PAP; ENZYMATIC METHOD, CREATININE

Catalog Number 05401470190

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received questionable high crep2 creatinine plus ver.2 results for seven patient samples from the cobas c 111 with ise analyzer serial number (b)(4).Refer to the attachment to the medwatch for all patient data.The erroneous results were not reported outside of the laboratory.There was no allegation of an adverse event.Calibration and qc results were acceptable and a general reagent issue could be excluded.The probe was replaced and the water quality was checked.

Manufacturer Narrative

Investigations have determined a reagent carryover to the crep2 (creatinine) or trigl (triglycerides) test can occur if a preceding test containing dextran sulfate is pipetted first and then followed by the chol2 (cholesterol gen.2) reagent.This carryover can result in discrepant, high results for crep2 and trigl.Installation of extra wash cycles avoids this issue.Customers have been provided with the workaround.

• Brand Name: CREA PAP
• Type of Device: ENZYMATIC METHOD, CREATININE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7867943
• MDR Text Key: 119933610
• Report Number: 1823260-2018-03083
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 04015630926862
• UDI-Public: 4015630926862
• 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: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 05401470190
• Device Lot Number: 33043101
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1