MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ISE INDIRECT K+ FOR GEN.2; ELECTRODE, ION SPECIFIC, POTASSIUM

Catalog Number 03144143001

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2020

Event Type  malfunction  

Event Description

The initial reporter stated they received higher than expected results for two patient samples tested with ca2 calcium gen.2 and ise indirect k for gen.2 on a cobas 6000 c (501) module at the customer site and an unknown cobas 8000 analyzer used at a second site.The initial values were reported outside of the laboratory where they were questioned by a physician.The reporter stated that the calcium and k results measured from the samples did not agree with the clinical picture of the patients.This medwatch will apply to k.Please refer to the medwatch with patient identifier (b)(6) for information related to calcium.The first patient sample initially resulted with a k value of 5.7 mmol/l accompanied by a data flag.The sample was repeated, resulting with a value of 5.68 mmol/l accompanied by a data flag.The sample was repeated at a second site on a cobas 8000 analyzer, resulting with a value of 5.7 mmol/l accompanied by a data flag.The second patient sample initially resulted with a k value of 5.5 mmol/l accompanied by a data flag.The sample was repeated, resulting with a value of 5.56 mmol/l accompanied by a data flag.The sample was repeated at a second site on a cobas 8000 analyzer, resulting with a value of 5.5 mmol/l accompanied by a data flag.The serial number of the customer's c 501 analyzer is (b)(4).The model and serial number of the cobas 8000 analyzer used at the second site was requested, but not provided.

Manufacturer Narrative

The field service engineer checked rinse volume and gear pump pressure; these were acceptable.Precision studies were performed.Calibration and controls were run and all results were within established ranges.Calibration and controls were acceptable.Upon review of the alarm trace, no relevant alarms were observed.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ISE INDIRECT K+ FOR GEN.2
• Type of Device: ELECTRODE, ION SPECIFIC, POTASSIUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10478397
• MDR Text Key: 213901174
• Report Number: 1823260-2020-02161
• Device Sequence Number: 1
• Product Code: CEM
• Combination Product (y/n): N
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03144143001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 08/03/2020
• Supplement Dates FDA Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR