MAUDE Adverse Event Report: ROCHE DIAGNOSTICS C8100 TYPE ALPHA; AUTOMATED SAMPLE PROCESSING UNIT

Catalog Number 07439822001

Device Problem Unintended Movement (3026)

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

Event Date 01/22/2024

Event Type  malfunction  

Event Description

We received an allegation that the c8100 v2 type alpha (ipb,dsp,obs,crw,cu) did not process a patient sample tube properly producing a questionable glucose result.The initial result was called to the hospital floor.The reporter noticed that the patient sample was not centrifuged prompting the rerun of the patient sample.The initial result from the cobas pro c503 was 48 m g/dl.The repeat result from an unknown analyzer was 91 mg/dl.The repeat result was deemed correct. .

Manufacturer Narrative

The reagent lot number and the expiration date were requested but not provided.The serial number of the cobas pro c 503 is (b)(6).The reporter stated that the patient sample was centrifuged and checked by the instrument but was ejected due to barcode read errors.The reporter stated that after this, the patient sample was remixed and reloaded on the instrument because the pictures after the patient sample was reloaded showed blood towards the top of the tube near the cap which was not seen in the pictures that were taken before.The reporter stated that it appeared the operators were not checking the sample tubes to ensure that they were centrifuged before reloading them.The investigation is ongoing.

Manufacturer Narrative

The investigation determined the event was due to the customer's product handling (uncentrifuged sample tube sent from the c8100 to the cobaspro).Product labeling states "the input buffer (ipb) module cannot detect whether a sample is centrifuged and does not read the two-dimensional barcode of an aliquot placed in a non-configured tray.If you put a sample that needs centrifugation into the tray for centrifuged samples, that sample is not centrifuged.If you put a sample that has been centrifuged into a normal tray, that sample is centrifuged again.Pay special attention to the locations of configured trays.".

• Brand Name: C8100 TYPE ALPHA
• Type of Device: AUTOMATED SAMPLE PROCESSING UNIT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18701924
• MDR Text Key: 335414847
• Report Number: 1823260-2024-00425
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

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: 07439822001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 03/14/2024
• 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