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

Catalog Number	05401470190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).(b)(6).
Event or Problem 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.
Additional 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
• Common Device Name: ENZYMATIC METHOD, CREATININE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7867943
• Report Number: 1823260-2018-03083
• Device Sequence Number: 13883199
• Product Code: JFY
• UDI-Device Identifier: 04015630926862
• UDI-Public: 4015630926862
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K024098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 05401470190
• Device Lot Number: 33043101
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1