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

Model Number CREP G2

Device Problem High Test Results (2457)

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

Event Date 03/08/2021

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi) # (b)(4).The customer noted a "film", possibly a film bubble, on the reagent pack that was originally used for testing of the affected samples.The customer also mentioned seeing excessive >abs flags and negative results in their information system.The field service representative checked the instrument specifications, all systems met specifications.He performed a hardware check by test performance, all tests meet specifications.He verified that the system is up and running without alarms.The investigation is ongoing.

Event Description

The initial reporter received questionable creatinine plus ver.2 results for 11 patient samples on a cobas 8000 c502 module.Sample (b)(6): the initial result was 1.4 mg/dl and the repeated result was 0.8 mg/dl.The initial result failed a delta check, but was not properly addressed by the technician.Sample (b)(6): the initial result was 1.35 mg/dl and the repeated result was 1.05 mg/dl.Sample (b)(6): the initial result was 1.00 mg/dl and the repeated result was 0.62 mg/dl.Sample (b)(6): the initial result was 1.33 mg/dl and the repeated result was 1.00 mg/dl.Sample (b)(6): the initial result was 1.77 mg/dl and the repeated result was 1.36 mg/dl.Sample (b)(6): the initial result was 1.28 mg/dl and the repeated result was 0.82 mg/dl.Sample (b)(6): the initial result was 1.49 mg/dl and the repeated result was 1.07 mg/dl.Sample (b)(6): the initial result was 0.96 mg/dl and the repeated result was 0.54 mg/dl.Sample (b)(6): the initial result was 1.41 mg/dl and the repeated result was 0.76 mg/dl.Sample (b)(6): the initial result was 1.43 mg/dl and the repeated result was 1.06 mg/dl.Sample (b)(6): the initial result was 1.36 mg/dl and the repeated result was 1.05 mg/dl.The repeated results were performed on another c502 analyzer.The initial results were reported outside of the laboratory.Amended reports were sent notifying medical personnel that the correct results were the repeated results.The reagent lot number is 51387001 with an expiration date of 31-jul-2021.

Manufacturer Narrative

D4 unique device identifier (udi) (b)(4).The customer removed the current creatinine reagent pack from the analyzer.The customer did not report any further issues.The last calibration was done on (b)(6) 2021 and was acceptable.On (b)(6) 2021 and at the beginning of the day, qc recovery was acceptable.The customer's qc results were out of range later in the day "around 05:17 to 0:20." the alarm trace contained abnormal aspiration, abnormal aspiration (sample probe), sample clot detection, and sample short errors.These are indicators of possible poor sample quality.The customer's sample pre-analytical details were requested but not provided.The investigation determined the customer's actions of removing the reagent pack resolved the issue.Updated medwatch fields: d1, d2, d4, g1, and g4.

• 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: 11604941
• MDR Text Key: 269655401
• Report Number: 1823260-2021-00981
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

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 Expiration Date: 07/31/2021
• Device Model Number: CREP G2
• Device Catalogue Number: 03263991190
• Device Lot Number: 51387001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 04/01/2021
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1