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

Catalog Number 03263991190

Device Problem Non Reproducible Results (4029)

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

Event Date 12/13/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the integra 400 plus instrument is (b)(6).The investigation is ongoing.Medwatch field e1 initial report street was provided as (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the cobas integra creatinine plus ver.2 assay on a cobas integra 400 plus analyzer.The clinician questioned the initial value because the patient is believed to have a normal creatinine value since the patient did not have a history of high creatinine.The primary serum tube of the sample initially resulted in a creatinine value of 2.46 mg/dl.The primary serum tube was re-centrifuged and repeated, resulting in a creatinine value of 6.36 mg/dl.The primary serum tube was re-centrifuged a second time and repeated, resulting in a creatinine value of 5.73 mg/dl.On 14-dec-2023, the primary tube was transferred to a plastic aliquot tube, centrifuged, and repeated, resulting in a creatinine value of 5.74 mg/dl.The aliquot tube was centrifuged again and repeated on 14-dec-2023, resulting in a creatinine value of 5.84 mg/dl.On 19-dec-2023, serum from the primary tube was tested at another site on an unknown instrument, resulting in a creatinine value of 0.7 mg/dl.On 20-dec-2023, the primary tube serum sent to the other site was tested on the customer's analyzer, resulting in a creatinine value of 0.70 mg/dl on 20-dec-2023, a plasma tube collected at the same time as the primary tube was repeated on the customer's analyzer, resulting in a creatinine value of 0.69 mg/dl.On 20-dec-2023, the plastic aliquot tube of the sample was repeated, resulting in a creatinine value of 5.85 mg/dl.On 22-dec-2023, the plastic aliquot tube of the sample was repeated, resulting in a creatinine value of 5.84 mg/dl.

Manufacturer Narrative

The same patient had a urine sample collected and tested on (b)(6) 2023 for microalbumin on the integra 400 plus.The microalbumin result was 34.5 mg/dl.This value was reported to the clinician.This patient also had a urine sample collected and tested on (b)(6) 2023 for microalbumin on the integra 400 plus.The microalbumin result was 13.26 mg/dl.The microalbumin reagent lot number and expiration date were requested, but not provided.

Manufacturer Narrative

The calibration data was within range.A review of log information from the instrument determined that a probe replacement occurred on (b)(6) 2023, but was aborted.A replacement of a second probe had not been done for the last year.To ensure proper accuracy, it is recommended to change both probes after 50000 tests.The customer measured more than 123000 tests over the last year.In such a usage, the probes should have been replaced at least 2 times over the last year.After changing the probes, no further discrepancies occurred.The investigation determined that changing the probes resolved the issue.The investigation did not identify a product issue.

• Brand Name: COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
• Type of Device: ENZYMATIC METHOD, CREATININE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; rotkreuz 6343 ; WZ 6343
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18457228
• MDR Text Key: 332730971
• Report Number: 1823260-2024-00060
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): Y
• Reporter Country Code: ID
• PMA/PMN Number: K951595
• 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,Followup
• Report Date: 03/06/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03263991190
• Device Lot Number: 734446
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female