MAUDE Adverse Event Report: ROCHE DIAGNOSTICS K ELECTRODE; ELECTRODE, ION SPECIFIC, POTASSIUM

Catalog Number ASKU

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)

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

Event Date 01/12/2024

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).The investigation is ongoing.

Event Description

There was an allegation of questionable na electrode, k, and cl results for 1 sample, questionable na electrode, k results for 1 sample, and questionable na electrode results for 4 samples on a cobas 6000 c 501 module.Sample 1 (id: (b)(6), the initial na result was 124 mmol/l and the repeated result was 138 mmol/l.The initial k result was 3.90 mmol/l and the repeated result was 4.45 mmol/l.The initial cl result was 88.6 mmol/l and the repeated result was 98.4 mmol/l.Sample 2 (id: (b)(6), the initial na result was 123 mmol/l and the repeated result was 137 mmol/l.The initial k result was 3.86 mmol/l and the repeated result was 4.28 mmol/l.Sample 3 (id: (b)(6), the initial na result was 130 mmol/l and the repeated result was 140 mmol/l.Sample 4 (id: (b)(6), the initial na result was 133 mmol/l.And the repeated result was 142 mmol/l.Sample 5 (id: (b)(6), the initial na result was 128 mmol/l and the repeated result was 135 mmol/l.Sample 6 (id: (b)(6), the initial na result was 130 mmol/l and the repeated result was 138 mmol/l.The repeated results were obtained using an alternate instrument and they were believed to be correct.The results were reported outside of the laboratory.The samples were repeated because the results were questioned by the physician.This medwatch will apply to the k electrode.Please refer to the medwatch with a1.Patient identifier pt (b)(6) for information related to the na electrode and medwatch with a1.Patient identifier pt (b)(6) for information related to the cl electrode.

Manufacturer Narrative

The field service representative found a broken internal standard (is) bath and is bath solenoids which was not allowing aspiration of vacuum fangs.He replaced the is bath, is bath solenoids, and tubing to the vacuum pump.Once parts were changed he checked the instrument and performed an air purge and reagent primes.He verified the correct aspiration of the fangs, and performed ise checks.The customer performed calibration, qc, comparison checks, and precision checks.The customer's qc results were ok.There was no indication of a reagent issue.After service, no issues were reported by the customer.The investigation determined the service actions resolved the issue.

• Brand Name: K ELECTRODE
• Type of Device: ELECTRODE, ION SPECIFIC, POTASSIUM
• 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: 18670739
• MDR Text Key: 334953027
• Report Number: 1823260-2024-00377
• Device Sequence Number: 1
• Product Code: CEM
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare 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: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/08/2024
• 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