MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA GLUCOSE HK GEN. 3; HEXOKINASE, GLUCOSE

Catalog Number 04404483190

Device Problem Non Reproducible Results (4029)

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

Event Date 01/08/2024

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).It was noted that the samples were obtained in another center that manages its pre-analytical process (sample collection and incubation).The investigation is ongoing.

Event Description

There was an allegation of questionable cobas integra glucose hk gen.3 results for 5 patient samples and questionable cobas integra glucose hk gen.3 and chol2 results for 1 patient sample on a cobas 4000 c311 module.Patient 1 (sample id (b)(6)): on (b)(6) 2024 the initial glucose result was 138.5 mg/dl.The repeated result was 88.4 mg/dl.Patient 2 (sample id (b)(6)): on (b)(6) 2024 the initial glucose result was 131.7 mg/dl.The repeated result was 98.6 mg/dl.Patient 3 (no sample id provided): on (b)(6) 2024 the initial glucose result was 79.4 mg/dl.The questionable result was not reported outside of the laboratory as it did not match the patient's clinical history and the customer repeated the sample.The repeated result was 109.9 mg/dl.This result was believed to be correct.The sample was repeated on a c 111 analyzer and the result was 108.73 mg/dl.Patient 4 (sample id 7(b)(6)): on (b)(6) 2024 the initial glucose result was 60.6 mg/dl.The repeated result was 87.4 mg/dl.Patient 5 (sample id (b)(6)): on (b)(6) 2024 the initial glucose result was 79.4 mg/dl.The repeated result was 109.9 mg/dl.Patient 6 (sample id (b)(6)): on (b)(6) 2024 the initial glucose result was 16.6 mg/dl.The repeated result was 93.3 mg/dl.The initial chol2 result was 296 and the repeated result was 148.The unit of measurement for the chol2 results was not provided.This medwatch will apply to the glucose assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the chol2 assay.

Manufacturer Narrative

The customer's calibration and qc results were ok.There was no indication of a reagent issue.The field service representative found the fluids were not dispensing correctly.He found a dispensing acid wash.He exchanged a valve and a pipette and performed functional tests.He adjusted the washing comb, drained the condensation liquid, performed purges, and performed mechanism checks.After service, no issues were reported by the customer.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS INTEGRA GLUCOSE HK GEN. 3
• Type of Device: HEXOKINASE, GLUCOSE
• 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: 18650132
• MDR Text Key: 334884200
• Report Number: 1823260-2024-00335
• Device Sequence Number: 1
• Product Code: CFR
• Combination Product (y/n): Y
• Reporter Country Code: PE
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04404483190
• Device Lot Number: 74348401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• 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