MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS PRO ISE ANALYTICAL UNIT; CLINICAL CHEMISTRY ANALYZER

Catalog Number 08464537001

Device Problem Low Test Results (2458)

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

Event Date 02/07/2024

Event Type  malfunction  

Event Description

The initial reporter received questionable ise indirect na and k for gen.2 results from multiple patient samples tested on two cobas pro ise analytical units (cobas 1 and cobas 2).The reporter was able to provide the following examples of questionable results: sample a on (b)(6) 2024: the initial result was reported to the gynecologist who complained that the result was not plausible.The initial na result from cobas 1 was 131 mmol/l.The first repeat result from cobas 2 was 132 mmol/l.The second repeat result from cobas 1 after recalibration was 135 mmol/l.On (b)(6) 2024: the third repeat result from cobas 2 was 140.6 mmol/l.The fourth repeat result from the partner laboratory's abbott architect 8000 was 141 mmol/l.Sample b on (b)(6) 2024: the initial result was reported to the gynecologist who complained that the result was not plausible.The initial na result from cobas 1 was 133 mmol/l.The first repeat result from cobas 2 was 132 mmol/l.The second repeat result from cobas 1 after recalibration was 135 mmol/l.On (b)(6) 2024: the third repeat result from cobas 2 was 141.3 mmol/l.The fourth repeat result from the partner laboratory's abbott architect 8000 was 143 mmol/l.Sample c the initial na result from the laboratory's unspecified cobas pro was 121 mmol/l.The repeat result from the partner laboratory's abbott architect 8000 was 127 mmol/l.On (b)(6) 2024: sample (b)(4) the initial na result from cobas 1 was 126.6 mmol/l.The first repeat result from cobas 2 was 129.3 mmol/l.The second repeat result from the partner laboratory's abbott architect 8000 was 134 mmol/l.Sample (b)(4) the initial na result from cobas 1 was 127.1 mmol/l.The first repeat result from cobas 2 was 128 mmol/l.The second repeat result from the partner laboratory's abbott architect 8000 was 133 mmol/l.Sample (b)(4) the initial na result from cobas 1 was 121.4 mmol/l.The first repeat result from cobas 1 was 131 mmol/l.The second repeat result from cobas 2 was 123 mmol/l.The third repeat result from cobas 2 was 127 mmol/l.Sample (b)(4) the initial k result from cobas 1 was 3.75 mmol/l.The first repeat result from cobas 1 was 4.8 mmol/l.The second repeat result from cobas 2 was 3.83 mmol/l.The third repeat result from cobas 2 was 4.9 mmol/l.On (b)(6) 2024: sample (b)(4) the initial na result from cobas 1 was 108 mmol/l.The first repeat result from cobas 1 after a new calibration was 118.7 mmol/l.The second repeat result from cobas 2 was 108 mmol/l.The third repeat result from cobas 2 was 117.3 mmol/l.The initial k result from cobas 1 was 4.3 mmol/l.The first repeat result from cobas 1 was 4.7 mmol/l.The second repeat result from cobas 2 was 4.2 mmol/l.The third repeat result from cobas 2 was 4.69 mmol/l.

Manufacturer Narrative

The serial number of cobas pro ise analytical units (b)(6), the serial number of cobas pro ise analytical units - cobas 2 is (b)(6).The electrode lot numbers and their expiration dates were requested but not provided.The investigation is ongoing.

• Brand Name: COBAS PRO ISE ANALYTICAL UNIT
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• 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
• MDR Report Key: 18825060
• MDR Text Key: 336747110
• Report Number: 1823260-2024-00634
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K191899
• 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
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08464537001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2024
• 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