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

Catalog Number	03246353001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The customer initially complained about third party qc results for chloride (cl) after changing the electrode on a cobas 6000 c (501) module.Cl electrode lot # v0204 had been installed on (b)(6) 2018 and the customer had no qc issues with this electrode.On (b)(6) 2018 new cl electrode with lot # w9817 was installed.The reference electrode had last been replaced in (b)(6) 2018.Upon replacing the cl electrode, qc results shifted high.On (b)(6) 2018 the customer also questioned results for patients tested for cl.An ise check passed on the day of the event.When the ise's were calibrated, a calibration flag was generated for cl and the value was [-] 10.The tech didn't realize this and ran patient samples.Once the cl results began to show flags for delta checks, the tech stopped running patient samples.The tech re-calibrated and repeated patient samples.The customer provided data for 1 patient sample and the cl results were discrepant.The original cl result was 98 mmol/l.The repeat result was 97.6 mmol/l.After the tech re-calibrated the cl result was 109 mmol/l.The original result had been reported outside of the laboratory.The repeat results after re-calibration were believed to be correct.No adverse event occurred.The c501 module serial number was (b)(4).The customer received new third party qc material the week of (b)(6) 2018 but they continue to have issues.The roche qc material produced results within the acceptable range.The field service engineer (fse) visited the customer site and checked to make sure the electrodes were seated correctly.O-rings were checked.Ise checks x15 were run and all results were acceptable.The customer ran qc and all results were acceptable.
Additional Manufacturer Narrative
The investigation determined the root cause of the issue was the failed calibration at the customer site.

• Brand Name: ISE INDIRECT NA, K, CI FOR GEN.2
• Common Device Name: ELECTRODE, ION-SPECIFIC, CHLORIDE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7868054
• Report Number: 1823260-2018-03108
• Device Sequence Number: 11253883
• Product Code: CGZ
• UDI-Device Identifier: 08430215043561
• UDI-Public: 08430215043561
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03246353001
• Device Lot Number: W9817
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SUPPORTIVE CARE"; ACYCLOVIR; ALLOPURINOL; CHEMO DRUGS; DEXAMETHASONE; "SUPPORTIVE CARE"; ACYCLOVIR; ALLOPURINOL; CHEMO DRUGS; DEXAMETHASONE
• Patient Age: 40 YR
• Patient Weight: 63