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

Model Number CREP G2

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received a complaint from a doctor who saw an increase in patient values for crep2 creatinine plus ver.2 on the cobas 8000 c (701) module.The reporter stated they saw an increase in 10 units when comparing patient result mean data from october and november.The reporter stated they then tested patient samples from another site using a vitros instrument and saw a difference of around 22 umol/l for all samples.The reporter believes the issue is related to creatinine reagent lot 499631, which they started using (b)(6) 2020.The reporter provided data for seven patient samples with discrepant creatinine results when compared to results measured on the vitros analyzer at the second site.The values measured at the customer site were reported outside of the laboratory.The first sample resulted with a creatinine value of 80 umol/l on the c 701 analyzer, which resulted as 52 umol/l on the vitros analyzer.The second sample resulted with a creatinine value of 88 umol/l on the c 701 analyzer, which resulted as 66 umol/l on the vitros analyzer.The third sample resulted with a creatinine value of 95 umol/l on the c 701 analyzer, which resulted as 78 umol/l on the vitros analyzer.The fourth sample resulted with a creatinine value of 97 umol/l on the c 701 analyzer, which resulted as 79 umol/l on the vitros analyzer.The fifth sample resulted with a creatinine value of 101 umol/l on the c 701 analyzer, which resulted as 82 umol/l on the vitros analyzer.The sixth sample resulted with a creatinine value of 102 umol/l on the c 701 analyzer, which resulted as 83 umol/l on the vitros analyzer.The seventh sample resulted with a creatinine value of 108 umol/l on the c 701 analyzer, which resulted as 87 umol/l on the vitros analyzer.The serial number of the customer's c 701 analyzer is (b)(4).

Manufacturer Narrative

It was found during internal investigations that for reagent lot 499631, which was used for comparison results, an absolute positive bias for serum samples of 6-8 ¿mol/l exists.No product specifications are violated and customers can continue to use affected reagent lots.In some cases higher deviations can be observed at customer site, which can be explained by the combination of the test specification (8 ¿mol/l intercept plus 1.05 slope).In addition, it could occur for certain samples (especially in the lower concentration range) that the difference is higher.This effect is sample related.The customer started using a new creatinine reagent lot number and the results are acceptable.

• 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: 11094423
• MDR Text Key: 244805298
• Report Number: 1823260-2020-03438
• 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: 02/16/2021

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: 499631
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1