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

Catalog Number 03246353001

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The investigation is ongoing.

Event Description

The initial reporter received questionable ise indirect gen.2 na and cl results for one patient tested on a cobas 6000 c (501) module serial number (b)(4).It was requested but not provided if the initial results were reported outside the laboratory.The customer ultracentrifuged the sample and performed repeat testing due to the patient's sample containing lipemia.The patient's initial results were na 146 mmol/l and cl 104 mmol/l.The patient's repeat results were na 162 mmol/l and cl 115.1 mmol/l.This medwatch is for (b)(6).

Manufacturer Narrative

The customer confirmed the patient's initial results were not reported outside the laboratory.The customer reported the ultracentrifuged results outside the laboratory.The customer performed additional testing with the patient's sample on a direct ise analyzer, phox ultra bga.The patient's results were na 169 mmol/l, k 4.29 mmol/l and cl 122.1 mmol/l.

Manufacturer Narrative

The customer's sample handling was ok.Per product labeling, "intralipid does not interfere in the tested concentration range up to 2000 mg/dl intralipid (corresponding to an approximate l index of 2000).There is poor correlation between the l index (corresponds to turbidity) and the triglycerides concentration.Pseudohyponatremia may be seen with the lipemic specimens as a result of fluid displacement." the investigation did not identify a product problem.

• Brand Name: ISE INDIRECT K+ FOR GEN.2
• Type of Device: ELECTRODE, ION-SPECIFIC, CHLORIDE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10384196
• MDR Text Key: 202406726
• Report Number: 1823260-2020-01935
• Device Sequence Number: 1
• Product Code: CGZ
• Combination Product (y/n): N
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03246353001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1