MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 221 <6> SYSTEM; BLOOD GAS ANALYZER

Catalog Number 03337154001

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2022

Event Type  malfunction  

Manufacturer Narrative

The field service engineer found a contaminated cuvette.The investigation is ongoing.

Event Description

The initial reporter received questionable bilirubin results for one patient tested on a cobas b 221 6 roche omni s6 system.The patient's cobas 221 bilirubin result was 7.5 mg/dl.The bilirubin result did not match the patient's clinical status and the medical personnel requested a laboratory test.Within 25 minutes, the patient's total bilirubin result on a "humastar 600- humastar 200" laboratory analyzer was 10.73 mg/dl.The customer determined the laboratory result to be correct and the diagnosis and treatment were based on the laboratory result.The bilirubin reagent lot number and expiration date were requested but not provided.

Manufacturer Narrative

The results were obtained with separate patient samples.Another sample for the same patient was measured on 18-jun-2022 and the bilirubin result was 7.1 mg/dl for an arterial blood sample.The hematocrit (hct) was 57.2 % and the thb was 19.28 g/dl.The hct and thb values were in the normal physiological reference ranges for neonates.The (mchc = hemoglobin (g/dl) : hematocrit) result was 33.71 g/dl which indicated an adequate thb-hct proportion.The b 221 bilirubin value was plausible regarding the hct value and the sample measurement result from the next day.For the plasma sample, only the bilirubin results were visible and no plausibility check could be performed.It was unknown why the customer thought that the even higher bilirubin value was correct.It was not clear if the cuvette was contaminated before or after the issue.The customer's qc values for bilirubin and all coox parameters were within range.The qc combitrol plus b material for level 2 and level 3 had expired on 31-may-2022.Expired material should not have been used for validating the parameter performance of the b 221.On 17-jun-2022 a "separator error" appeared frequently on the b 221.Based on the provided data no sample-related issue could be identified.For the b 221 sample, a syringe was used for venous blood sampling.The use of syringes greatly increases the risk of hemolysis and clot formation.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS B 221 <6> SYSTEM
• Type of Device: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15086608
• MDR Text Key: 304547502
• Report Number: 1823260-2022-02159
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 04015630018345
• UDI-Public: 04015630018345
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K032311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2022

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: 03337154001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 08/19/2022
• Supplement Dates FDA Received: 09/12/2022
• 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
• Patient Sequence Number: 1
• Patient Age: 2 DA
• Patient Sex: Female