N
Patient 1
UNIQUE IDENTIFIER (UDI)#: (B)(4).
MAUDE MDR 6403539
- MDR report key
- 6403539
- Report number
- 1823260-2017-00556
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-02-24
- Date received
- 2017-03-14
- Adverse event
- 0
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 105
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- NA MICHAEL LESLIE
- Address
- 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US
- Phone
- 317-317-3175
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 | COBAS 6000 C501 MODULE | CLINICAL CHEMISTRY ANALYZER | ROCHE DIAGNOSTICS | LBS | C501 | 05860636001 | NA | R | Y | |||
| 1 | COBAS 6000 C501 MODULE | CLINICAL CHEMISTRY ANALYZER | ROCHE DIAGNOSTICS | JJE | C501 | 05860636001 | NA | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-03-14 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER RECEIVED ANALYZER ALARMS AND QUESTIONABLE LOW RESULTS FOR PATIENT SAMPLES. OF THE DATA PROVIDED FOR TWO PATIENT SAMPLES, ONLY THE ERRONEOUS RESULT FOR ONE SAMPLE WAS REPORTED OUTSIDE THE LABORATORY. THE HDLC3 HDL-CHOLESTEROL PLUS 3RD GENERATION RESULT WAS 3MG/DL WITH A DATA FLAG. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULT ON (B)(6) 2017 FROM THE SAME TUBE AND FROM ANOTHER TUBE FROM THE SAME VENIPUNCTURE WAS 48 MG/DL. THIS RESULT WAS BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 14048201 WITH AN EXPIRATION DATE OF 01/31/2018. THE FIELD SERVICE REPRESENTATIVE FOUND THE SAMPLE PROBE MECHANISM WAS MISALIGNED IN VARIOUS POSITIONS. HE PERFORMED MECHANICAL AND ELECTRICAL ALIGNMENTS OF THE SAMPLE PROBE MECHANISM. HE PERFORMED MECHANICAL, ELECTRICAL, AND FLUIDIC CHECKS OF THE INSTRUMENT WITHOUT ERRORS. THE CUSTOMER WAS ABLE TO RUN QC AND PATIENT SAMPLES. HE FOUND THE INSTRUMENT WAS PERFORMING TO SPECIFICATIONS. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. A LIKELY ROOT CAUSE WAS THE PREANALYTIC HANDLING OF THE SAMPLE. BASED ON THE PROVIDED ANALYZER ALARM INFORMATION, ON THE DATE OF THE EVENT THERE WAS NO ANALYZER ALARM NEAR THE TIME THE SAMPLE WAS BEING PIPETTED. THEREFORE THE ISSUE FOUND BY THE FIELD SERVICE REPRESENTATIVE SHOULD NOT HAVE AFFECTED THIS SAMPLE.