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

Catalog Number 05168791190

Device Problem Non Reproducible Results (4029)

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

Event Date 02/01/2024

Event Type  malfunction  

Event Description

There was an allegation of a questionable gluc hk gen.3 (glucose) result from the cobas 8000 c702 module.The initial result of 1.67 mmol/l, accompanied by a data flag, and automatically repeated as 2.71 mmol/l.The repeat analyses performed from the same tube (not recentrifuged) on two other laboratory instruments confirmed the lower initial result.The exact result was not provided and was reported outside of the laboratory.

Manufacturer Narrative

The cobas 8000 c702 module serial number was (b)(6).The model and serial number of the analyzer used on the repeat tests at the customer site were requested, but not provided.The investigation is ongoing.

Manufacturer Narrative

On (b)(6) 2024, the controls were within the expected range, and on (b)(6) 2024, the controls were higher than the expected range.An allegation of new questionable results (patient 02 and patient 03) was reported by the customer.The new measurements were performed with reagent gluc hk gen.3 lot no.772291 on (b)(6) 2024: patient 02: the initial glucose result was 1.08 mmol/l, accompanied by a data flag, and repeated as 5.91 mmol/l and 5.74 mmol/l.Patient 03: the initial glucose result was 28.19 mmol/l, and repeated as 8.51 mmol/l, 27.71 mmol/l, and 28.31 mmol/l.The investigation is ongoing.

• Brand Name: COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
• 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: 18787160
• MDR Text Key: 336318388
• Report Number: 1823260-2024-00550
• Device Sequence Number: 1
• Product Code: CFR
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 03/27/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05168791190
• Device Lot Number: 752913
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• 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