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

Catalog Number	05122287001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer questioned results for 2 patients tested on 2 cobas b 123 instruments located in the neonatal unit compared to a siemens 1265 blood gas analyzer.Based on the data provided, the results for ph, pco2 and po2, na, be, so2, methb and chco3 were discrepant.This medwatch will cover patient 2 tested on cobas b 123 instrument serial number (b)(4) and b 123 instrument serial number (b)(4).Refer to medwatch with patient identifier (b)(6) for information on patient 1 tested only on cobas b 123 instrument serial number (b)(4).Patient 1 was initially tested at 6:05 a.M.On b 123 instrument serial number (b)(4) with a ph result of 7.166, a pco2 result of 9.37 kpa and a po2 result of 4.48 kpa.At 6:19 a.M.A new sample was obtained and tested on b123 instrument serial number (b)(4)with a ph result of 7.151, a pco2 result of 10.55 kpa, a po2 result of 4.61 kpa, a be result of [-] 4.97 mmol/l, an so2 result of 71.9% and a methb result of 1.2%.Patient 1 did not appear to be in respiratory distress as the results indicated; the sample from 6:19 a.M.Was repeated on the siemens instrument with a ph result of 7.298, pco2 result of 6.52 kpa, a po2 result of 6.32 kpa, a be result of [-] 3.7 mmol/l, an so2 result of 89.2% and a methb result of 0.8%.The results from each instrument were from the same heel stick collected into the appropriate tubes.Patent 1 received no treatment.On (b)(6) 2018 patient 2 was tested via heel stick on cobas b 123 instrument (b)(4) at 11:46 p.M.Shortly after birth and the ph result was 7.219, the pco2 result was 9.17 kpa, the so2 result was 66.5% and the chco3 result was 27.5 mmol/l.The patient showed signs of respiratory distress and the patient was treated accordingly.The same sample was repeated on the siemens 1265 analyzer at 12:06 a.M.And the ph result was 7.346, the pco2 result was 5.46 kpa, the so2 result was 80.2% and the chco3 result was 21.9 mmol/l.On (b)(6) 2018 patient 2 had an na result of 134.8 mmol/l on b 123 instrument serial number (b)(4).The repeat result from b 123 instrument serial number (b)(4) was 140.0 mmol/l.There was no allegation that an adverse event occurred.The sensor cartridge lot number was 21582193 with an expiration date of 16-oct-2018.
Additional Manufacturer Narrative
Calibration and qc results were acceptable.The investigation reviewed the log files for the instrument and found that the high na result for patient 2 was due to an inaccurate calibration caused by a strong standby drift which could be related to the sensor or the blood sample.The customer used software version 4.10 on the instrument.The latest software versions of either 4.13 or 4.14 have an improved algorithm that detects unexpected standby drift.Retention sensors with lot 21582193 were tested and the results meet the specification.A product problem was not found for the sensor involved.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 7946344
• Report Number: 1823260-2018-03474
• Device Sequence Number: 14017118
• Product Code: CHL
• UDI-Device Identifier: 04015630036950
• UDI-Public: 04015630036950
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 11/07/2018

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: 09/19/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1