MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREP2; ENZYMATIC METHOD, CREATININE

Catalog Number 05168589190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 10/23/2023

Event Type  malfunction  

Event Description

The initial reporter received questionable crep2 (creatinine) results from four patient samples tested on the cobas 8000 cobas c 701 module.The initial results were not reported outside of the laboratory.The reporter complained that the creatinine results were high which prompted the rerun of the patient samples.Sample id (b)(6): on (b)(6) 2023, the initial result was 5.86 mg/dl.The repeat result was 1.03 mg/dl.Sample id (b)(6): on (b)(6) 2023, the initial result was 6.77 mg/dl.The repeat result was 4.03 mg/dl.Sample id (b)(6): on (b)(6) 2023, the initial result was 4.74 mg/dl.On (b)(6) 2023, the repeat result was 0.72 mg/dl.Sample id (b)(6): on (b)(6) 2023, the initial result was 2.85 mg/dl.On (b)(6) 2023, the repeat result was 1.00 mg/dl.

Manufacturer Narrative

The serial number of the customer's cobas 8000 cobas c 701 module is 18l0-07.The investigation reviewed the calibration on (b)(6) 2023; the results were within specifications.The investigation reviewed the quality control (qc) recovery; qc level 1 recovery was within +/- 2 standard deviations (sd); the results were within specifications.The investigation reviewed the alarm trace on (b)(6) 2023; the trace had frequent "abnormal sample aspiration" alarms.A precision check was performed with acceptable results.The investigation is ongoing.

Manufacturer Narrative

Medwatch fields d.Device identification, g1 and g4 pma / 510k (premarket numbers) were updated.The field service engineer (fse) checked the gear pump pressure, reagent probe inside and outside rinses, sample probe rinse, and cell rinse.He also checked the correct height of the reagent probes.The investigation determined the event was consistent with a maintenance-related issue.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

• Brand Name: CREP2
• Type of Device: ENZYMATIC METHOD, CREATININE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18152092
• MDR Text Key: 328379577
• Report Number: 1823260-2023-03635
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 04015630924998
• UDI-Public: 04015630924998
• Combination Product (y/n): Y
• Reporter Country Code: CO
• PMA/PMN Number: K100853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 05168589190
• Device Lot Number: 724718
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Male