MAUDE Adverse Event Report: ROCHE DIAGNOSTICS OPERATIONS INC. CHLORIDE ELECTRODE; ELECTRODE, ION-SPECIFIC, CHLORIDE

Catalog Number 03246353001

Device Problem Product Quality Problem (1506)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Quality control (qc) results were unacceptable after installation of multiple lots of roche diagnostics cobas chloride electrodes (cat # 03246353001).Roche sent a product bulletin on (b)(6) 2018 (tp-00394; chloride electrodes - discontinue use of certain lots).However, we have observed this qc issue on numerous lots not listed in the product bulletin.Chloride electrode lots which did not pass qc criteria at our institute include: a2072, b0625, b0094, a3760, w5233, x1881, x1882, x6230, y7004, y7200, and y8413.Affected electrodes were not placed into clinical use by our lab, therefore no pt results have been affected at our facility.

• Brand Name: CHLORIDE ELECTRODE
• Type of Device: ELECTRODE, ION-SPECIFIC, CHLORIDE
• Manufacturer (Section D): ROCHE DIAGNOSTICS OPERATIONS INC. ; indianapolis IN 46250
• MDR Report Key: 8042449
• MDR Text Key: 126635958
• Report Number: MW5081091
• Device Sequence Number: 3
• Product Code: CGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/02/2018
• 11 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 03246353001
• Device Lot Number: B0094
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1