MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8100; AUTOMATED PREANALYTICAL SYSTEM

Model Number 8100

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2020

Event Type  malfunction  

Event Description

The initial reporter stated that the cobas 8100 pre-analytics system sent one whole blood patient sample to the cobas 8000 ise module and cobas 8000 c 502 module analyzers, causing discrepant results to be generated for alp2 alkaline phosphatase acc.To ifcc gen.2 and ise indirect k for gen.2.Incorrect results were reported outside of the laboratory.The sample was initially loaded into a tray designated to skip the centrifuge unit and decapping unit of the cobas 8100 system.There was an error with the sample and it was ejected into an error tray.The error indicated the sample had a cap and needed to have the cap removed for another unit in the cobas 8100 system.The sample was then reloaded into a rack designated to be processed by all units of the cobas 8100 system.After the sample was processed by the cobas 8100 system, it remained uncentrifuged and it was sent as whole blood to the ise module and c502 module.When measured on the c502 module, the alp result of the whole blood sample was 213 u/l.The sample was repeated, resulting with an alp value of 107 u/l, which was deemed to be correct.When measured on the ise module, the k result of the whole blood sample was 4.7 mmol/l.The sample was repeated, resulting with a k value of 3.9 mmol/l, which was deemed to be correct.The alp reagent and k electrode lot numbers and expiration dates were requested, but not provided.

Manufacturer Narrative

The investigation determined the issue was caused by human error.As the system had already read the barcode of the sample when it was first loaded, the system designated the sample as already having been centrifuged when it was loaded on the system a second time.When reloading the sample, the customer is to change the sample status in the system software to designate the sample as being uncentrifuged.

• Brand Name: COBAS 8100
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10065971
• MDR Text Key: 204437658
• Report Number: 1823260-2020-01245
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8100
• Device Catalogue Number: 07439920001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BENADRYL; CITRIC ACID SOLUTION; FAMOTIDINE; LACTATE RINGERS; NA CITRATE; NARCAN; NORMODYNE; TYLENOL
• Patient Age: 30 YR
• Patient Weight: 121