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

Model Number	CREP G2
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem 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.
Additional 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
• Common Device Name: ENZYMATIC METHOD, CREATININE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12315760
• Report Number: 1823260-2021-02354
• Device Sequence Number: 3812383
• Product Code: JFY
• UDI-Device Identifier: 04015630924998
• UDI-Public: 04015630924998
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K024098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2021

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1