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 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received questionable sodium results from a cobas b 123 < 4 > poc system after proficiency material was tested and the sensor was changed.Patient 1 result from the b123 analyzer was 118.4 mmol/l and the result from a cobas b221 analyzer was 140.3 mmol/l.The repeat result from the b123 analyzer was 125.1 mmol/l and the result from a cobas b221 analyzer was 139.9 mmol/l.Patient 2 result from the b123 analyzer was 116 mmol/l and the result from a cobas b221 analyzer was 130.7 mmol/l.On (b)(6) 2018, patient 3 result from the b123 analyzer was 131.4 mmol/l and the result from a cobas b221 analyzer was 125.1 mmol/l.It was unknown if any erroneous result was reported outside of the laboratory.There was no allegation of an adverse event.The sensor lot number was requested but was not provided.

Manufacturer Narrative

The results from the b123 analyzer were not used for diagnostic purposes.Quality controls failed on the analyzer on both (b)(6) 2018 and (b)(6) 2018 following the measurement of proficiency testing samples.The proficiency material caused the na sensor to become unstable, leading to the erroneous results.It was also noted that, due to differences in the methods, the results from the b123 and b121 are not comparable without the use of a correction factor on one or the other analyzer.This correction was not done.The lot number for the sensors are 21582791 and 21582991.

Manufacturer Narrative

1.Is it common for proficiency samples to cause such issues? usually proficiency testing materials are stabilized versions of a patients sample, therefore we are concerned if the proficiency testing materials can cause an assay to fail, the same could happen with patient samples as well.Answer: it is not common.This case is the first time we observed this situation for na parameter on a cobas b 123 instrument.In addition, the proficiency material used in this case was labeled for glu and lac.Weqas eqa samples which were used in this case were the glucose/ketone material.The customer used this material to create a precision profile for the glucose assay on the cobas b 123 as part of a verification process.Thus, the influence of this material on the other sensors is not clear.Limitations of proficiency testing material are apparent when there is a difference between the real measurement sample type, which in our case is whole blood, and the aqueous material that is actually used for proficiency testing purposes.In case of cobas b 123, cobas b 221, cobas b 121 the existence of whole blood cells is the key difference between blood and proficiency testing material.As a consequence, all parameters associated with blood cells need more care, in case they are considered for proficiency testing.2.Why is it necessary to have a correction factor for cobas b 123 vs.B 221.Do these analyzers use different sensors and calibration materials? answer: please note it is the b 221 and not the b 121 in this case.Ise results on the cobas b 123 poc system differ from that on the cobas b 221 system if no correction factor is applied.These differences can be easily explained because the cobas b 123 poc systems are referenced to a nist standard and the electrolyte results of cobas b 221 systems are referenced to flame, aqueous gravimetry and coulometry methods.As such these analyzers use different sensors and calibration materials.The various reference methods correlate to each other and by using the appropriate correlation factors on the cobas b 123 poc system or the cobas b 221 system same patient results can be achieved.

Manufacturer Narrative

Request from fda: have you completed your root cause investigation and confirmed that the proficiency testing material is the cause of the inaccurate na results? response from manufacturer: during the investigation, we found additional information regarding the wequas material that was used for proficiency testing.The customer used the weqas poct glucose and ketone material as proficiency material on the b123.It was confirmed by weqas, the provider of the material and located in the united kingdom, that the poct glucose and ketone material is not intended for the b123 and b221 instruments.Also, in 2016, the b123 was removed from the us market and is not currently sold or available for sale in the us.As such, the mdr was not required to be sent per regulation but was sent in error.The b 123 is not manufactured in the united states we have the b 221 that imported / distributed in the us, but it not considered similar to the b 123.Among other differences, the cobas b 123 poc systems are referenced to a nist standard and the electrolyte results of cobas b 221 systems are referenced to flame, aqueous gravimetry and coulometry methods.As such these analyzers use different sensors and calibration materials.

• 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
• MDR Report Key: 8151768
• MDR Text Key: 130634600
• Report Number: 1823260-2018-04786
• 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,Followup,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05122287001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/23/2018
• Initial Date FDA Received: 12/11/2018
• Supplement Dates Manufacturer Received: 11/23/2018; 11/23/2018; 11/23/2018
• Supplement Dates FDA Received: 03/04/2019; 03/27/2019; 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PATIENT 1 BUMETANIDE TABLET; PATIENT 1 ENOXAPARIN INJ; PATIENT 1 PLASMA LYTE INSUSION; PATIENT 1 PREDNISOLONE; PATIENT 1BENZYL PENICILLIN; PATIENT 3 DOXYCYCLINE; PATIENT 3 LEVOTHYROXINE; PATIENT 3 NEFOPAN; PATIENT 3 PARACETAMOL; PATIENT 3 TINZAPARIN INJ