MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 123 <4> SYSTEM; BLOOD GAS ANALYZER

Catalog Number 05122287001

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2019

Event Type  malfunction  

Manufacturer Narrative

The patient's age or date of birth were not provided, but it was stated the patient is a newborn.The event occurred in (b)(6).

Event Description

The initial reporter complained of questionable total bilirubin results from a cobas b 123 < 4 > poc system compared to either a cobas 6000 or a cobas 8000 system.The same newborn patient was tested multiple times over a three day period.From the data provided, there was one occurrence of a reportable malfunction.The total bilirubin result from the cobas b123 was 237 umol/l.The total bilirubin result from the laboratory was 288 umol/l.The erroneous result was reported outside of the laboratory.There was no allegation of an adverse event.The investigation is currently ongoing.

Manufacturer Narrative

The initial measurement was done at 6:00 on the lab analyzer, and the sample was measured again at 14:37 on the cobas b123.The 8.5 hour time difference may have an influence on the lower result from the b123.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS B 123 <4> SYSTEM
• Type of Device: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 8413177
• MDR Text Key: 138665513
• Report Number: 1823260-2019-01032
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K111188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

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: 05122287001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/12/2019
• Supplement Dates Manufacturer Received: 02/25/2019
• Supplement Dates FDA Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 DA