MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 123 SENSOR CART. BG/ISE/GLU/LAC; BLOOD GAS ANALYZER

Catalog Number 05170478001

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer complained of an erroneous low potassium (k) result from the cobas b 123 instrument.The initial k result from the b 123 instrument was 4.38 mmol/l.The same sample was tested on a beckman au5800 instrument and the k result was 7.08 mmol/l.The results were reported outside of the laboratory and provided to the patient.There was no allegation of an adverse event.The k electrode lot number was 21580496 with an expiration date of 02-jul-2018.Qc results were acceptable.

Manufacturer Narrative

Based on investigation of data logs from the b 123 instrument, the alleged k result of 4.38 mmol/l was measured on 15-may-2018.The k result from the beckman instrument was measured on 16-may-2018.The difference in k results from the b 123 instrument and the beckman instrument was due to comparing blood samples measured on 2 different days.An analysis of sensor data shows the slope of the sensor was well within limits and no abnormal signals were observed between 05-may-2018 and 18-may-2018.Based on the data provided, the cobas b 123 instrument functioned correctly.A product problem was not found.

• Brand Name: COBAS B 123 SENSOR CART. BG/ISE/GLU/LAC
• Type of Device: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7578218
• MDR Text Key: 110863375
• Report Number: 1823260-2018-01774
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• PMA/PMN Number: K111188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

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: 05170478001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 06/07/2018
• Supplement Dates Manufacturer Received: 05/16/2018
• Supplement Dates FDA Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR