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

Catalog Number	05122287001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer questioned results for 5 patients tested for sodium (na) on a cobas b 123 instrument located in the intensive care unit of the hospital.The customer provided discrepant high results for 1 patient.The na result from a beckman au5800 laboratory analyzer was 139 mmol/l at 9:21 a.M.The results from the b 123 instrument were 138 mmol/l at 10:03 a.M., 153 mmol/l at 2:49 p.M.And 142 mmol/l at 6:53 p.M.The customer replaced the na sensor cartridge at approximately 1:30 p.M.All calibrations passed.The result of 153 mmol/l was thought to be too high.Hospital staff suspected it was incorrect and did not take any action based on it.On (b)(6) 2018 the patient had an na result from the beckman au5800 analyzer of 142 mmol/l.There was no allegation that an adverse event occurred.The na sensor cartridge lot number was 21581791.The expiration date was not provided.The field service engineer (fse) visited the customer site and carried out a sensor simulator test.The results showed the sensor was ok.The system passed all calibrations and qc.No instrument issues were identified.
Additional Manufacturer Narrative
The data provided indicates a drift occurred after the installation of the na sensor cartridge lot number of 21581791 on 15-jun-2018.The drift led to the observed high na results.After a few hours, the drift returned to normal levels.The na sensor cartridge installed on 15-jun-2018 was not brand new.It had been installed on a different instrument 2 days earlier on 13-jun-2018.No qc was run on the b 123 instrument after the na sensor cartridge was installed or prior to running patient samples.Levels 1 and 3 of the autoqc pack were also empty at the time.A scheduled qc (such as one that would be automatically done after installing a new sensor cartridge) that is not completed is considered as failed qc and a "qc lock" or warning is displayed for all parameters.In this case, the b 123 instrument was configured to produce a "qc warning" but not a "qc lock." this meant that the b 123 instrument showed results with a "q" data flag on the result screen and the instrument printouts.Which should have alerted the customer to the issue.A new autoqc pack was installed and 3 levels of qc were run on 15-jul-2018 between 3:58 p.M.And 4:40 p.M.With acceptable results.The high na result of 153 mmol/l at 2:49 p.M.Had been run on the b 123 system prior to proper qc being performed.
Additional Manufacturer Narrative
Product labeling provides information related to qc protocols and warns users of ignoring qc results.The b 123 instrument produced results with "q" data flags alerting the customer of an issue.A product problem was not identified.

• Brand Name: COBAS B 123 <4> SYSTEM
• Common Device Name: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7739161
• Report Number: 1823260-2018-02539
• Device Sequence Number: 1118656
• Product Code: CHL
• UDI-Device Identifier: 04015630036950
• UDI-Public: 4015630036950
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K111188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2018

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: 05122287001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 07/16/2018; 07/16/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 08/15/2018; 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1