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

Model Number CREP G2

Device Problems Imprecision (1307); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/17/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The initial reporter received questionable crep2 creatinine plus ver.2 results for multiple patient samples with the cobas 8000 cobas c 701 module serial number (b)(4) between (b)(6) 2021.The reporter stated the calibration looked different than other historical calibrations but was acceptable and qc was in range.Upon performing qc again, the reporter noticed a shift and decided to repeat a couple of patient samples and the results were not in agreement.The reporter then replaced the reagent pack, recalibrated and the calibration was typical of what was observed in the past.The reporter then repeated all samples tested between (b)(6) 2021.The following are examples of questionable results for 3 patient samples: sample id (b)(6).The initial result was 0.84 mg/dl.The repeated result was 1.06 mg/dl.Sample id (b)(6).The initial result was 0.91 mg/dl.The repeated result was 1.10 mg/dl.Sample id (b)(6).The initial result was 0.83 mg/dl.The repeated result was 1.03 mg/dl.The questionable results were reported outside of the laboratory.The repeated results were deemed correct and corrected reports were issued.

Manufacturer Narrative

The investigation found level 1 of qc was outside 3sd on the date of the event and level 3 was acceptable.The investigation determined the customer¿s actions resolved the issue.

• 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: 12315760
• MDR Text Key: 268312596
• Report Number: 1823260-2021-02354
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: CREP G2
• Device Catalogue Number: 05168589190
• Device Lot Number: 54103201
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1