MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LDL-CHOLESTEROL PLUS 2ND GENERATION; SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN

Catalog Number	07005717190
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable ldl-cholesterol plus 2nd generation results for 1 patient sample on a cobas 6000 c 501 (ul) v module, serial number (b)(4).The direct ldl result was 204.2 mg/dl and the total cholesterol result was 131 mg/dl.The physician questioned the result due to the results not meeting the clinical picture of the patient.The patient's doctor manually calculated the ldl using the friedewald formula and the calculated ldl result was 58 mg/dl.This result was considered to be correct.The sample tests were repeated on (b)(6) 2022 and similar results were observed.Numerical result values for the repeated results were not provided.
Additional Manufacturer Narrative
The sample was discarded, and could not be returned for investigation.The field service representative performed hardware and precision checks.He checked the gear pump pressure and rinse mechanism volumes.All controls were acceptable and the system is performing within specification.The alarm trace showed sample short and abnormal aspiration alarms, indicating poor sample quality.The investigation determined the issue to be consistent with an interferent within the patient sample.

• Brand Name: LDL-CHOLESTEROL PLUS 2ND GENERATION
• Common Device Name: SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14236534
• Report Number: 1823260-2022-01206
• Device Sequence Number: 11959890
• Product Code: MRR
• UDI-Device Identifier: 04015630934584
• UDI-Public: 04015630934584
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K012287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 07005717190
• Device Lot Number: 53583701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NORVASK; SIMVISTATIM; ZOCOR
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 71 KG