MAUDE Adverse Event Report: ROCHE DIAGNOSTICS AVL CALCIUM ELECTRODE; ELECTRODE, ION SPECIFIC, CALCIUM

Catalog Number 03110354180

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Event Description

The customer received erroneous avl ca++ electrode (ca++) results for 3 patient samples on an electrolyte analyzer w/o starterkit 9180 (avl) serial number (b)(4).For patient 1 the initial ca++ result was 12.0 mg/dl and the repeat result was 12.35 mg/dl.The ca++ result was 1.18 mg/dl from the same sample on an abl800 gasometer.For patient 2 on (b)(6) 2018 the initial ca++ result of 12.89 mg/dl.The ca++ result was 1.06 mg/dl from the same sample on an abl800 gasometer.A new sample was collected and the ca++ result of 11.5 mg/dl.The ca++ result was 1.02 mg/dl with the new sample on an abl800 gasometer.For patient 3 on (b)(6) 2018 the initial ca++ result of 15.18 mg/dl.The ca++ result was 1.43 mg/dl from the same sample on an abl800 gasometer.The results on the abl800 gasometer were considered to be correct.No erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.The qc from both methods were within the expected range.There were no discrepancies observed for other patient samples.

Manufacturer Narrative

All of the electrodes were replaced.

Manufacturer Narrative

The investigation was unable to find a definitive root cause.

• Brand Name: AVL CALCIUM ELECTRODE
• Type of Device: ELECTRODE, ION SPECIFIC, CALCIUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7333427
• MDR Text Key: 102750606
• Report Number: 1823260-2018-00786
• Device Sequence Number: 1
• Product Code: JFP
• Combination Product (y/n): N
• PMA/PMN Number: K961458
• 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: 05/01/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 03110354180
• Device Lot Number: 21573547
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/13/2018
• Supplement Dates Manufacturer Received: 02/23/2018; 02/23/2018
• Supplement Dates FDA Received: 04/11/2018; 05/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PATIENT 1: AMOXICILLIN; PATIENT 1: AZITHROMYCIN; PATIENT 1: CLAVULANATE; PATIENT 2: CEFEPIME; PATIENT 2: METRONIDAZOLE