MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ONLINE TDM ACETAMINOPHEN GEN.2; ACETAMINOPHEN TEST

Catalog Number 06769942190

Device Problem Low Test Results (2458)

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

Event Date 03/12/2024

Event Type  malfunction  

Event Description

The initial reporter received a questionable aceta acetaminophen result from one patient sample tested on the cobas 8000 cobas c 502 module.The reporter stated that the results were coming in low prompting the rerun of the patient sample on another c 502 module.The initial result from the module was 0.4 ug/ml with a data flag.The repeat result from the other module was 124 ug/ml.The repeat result was deemed correct. .

Manufacturer Narrative

The serial number of the cobas 8000 cobas c 502 module is (b)(6).The investigation is ongoing.

Manufacturer Narrative

Medwatch fields d.Device identification, g1 and g4 pma / 510k (premarket numbers) were updated.The investigation reviewed the calibration performed on (b)(6) 2024.The results were within specifications.The investigation reviewed the qc recoveries.The recoveries were within the +/-2 standard deviation (sd) range.There was no indication of a performance issue with the reagent.The investigation reviewed the alarm trace.The alarm trace did not indicate any issues.The field service engineer (fse) inspected the module and determined the event was caused by a defective pressure sensor.The fse then replaced the defective pressure sensor.He also performed adjustments to the sample probe assembly using service software.He also replaced the leaking syringe barrel on the sample syringe assembly.He performed a probe check after adjustment of the sample probe and a pressure sensor check with successful results.The customer performed calibration and qc with successful results.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

• Brand Name: ONLINE TDM ACETAMINOPHEN GEN.2
• Type of Device: ACETAMINOPHEN TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19042691
• MDR Text Key: 339689656
• Report Number: 1823260-2024-01037
• Device Sequence Number: 1
• Product Code: LDP
• UDI-Device Identifier: 04015630935031
• UDI-Public: 04015630935031
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K141928
• 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
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06769942190
• Device Lot Number: 70983901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• 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
• Patient Age: 56 YR
• Patient Sex: Female