N
Patient 1
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).
MAUDE MDR 5628948
- MDR report key
- 5628948
- Report number
- 1628664-2016-00119
- Event key
- 0
- Event type
- 3
- Date received
- 2016-05-03
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 105
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- NOEMI ROMERO-KONDOS, RN BSN
- Address
- 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 ABBOTT PARK IL 60064 US
- Phone
- 224-224-2246
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 | ARCHITECT C16000 SYSTEM | AUTOMATED CHEMISTRY ANALYZER | ABBOTT MANUFACTURING INC | JFM | 03L77-01 | Y | Y | |||||
| 1 | ARCHITECT C16000 SYSTEM | AUTOMATED CHEMISTRY ANALYZER | ABBOTT MANUFACTURING INC | JJE | 03L77-01 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-05-03 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER REPORTS FALSELY ELEVATED CLIN CHEM TOTAL BILIRUBIN ASSAY RESULTS GENERATED ON FOUR PEDIATRIC PATIENT SAMPLES TESTED ON AN ARCHITECT C16000 ANALYZER (SN: (B)(4)). THE FOLLOWING WAS PROVIDED (RESULTS IN MG/DL): PATIENT #1: 19.9 AND RETESTED ON A SECOND ANALYZER IN THE LAB = 2.1. PATIENT #2: 10.3 AND RETESTED ON A SECOND ANALYZER IN THE LAB = 0.3. PATIENT #3: 6.5 AND RETESTED ON A SECOND ANALYZER IN THE LAB = 1.4. PATIENT #4: 12.8 AND RETESTED ON A SECOND ANALYZER IN THE LAB = 0.5. (THE SECOND ANALYZER IS AN ARCHITECT C8000 ANALYZER, SN: (B)(4)). THIS CUSTOMER USES A NORMAL REFERENCE RANGE OF 0.1 - 1.0 MG/DL. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB WITH NO REPORTED PATIENT IMPACT. THE CUSTOMER HAS TAKEN THIS ANALYZER OFFLINE AND IS REQUESTING A SERVICE CALL.
N
Patient 1
AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) VISITED THE CUSTOMER SITE AND REPLACED THE SAMPLE PROBE. THE FSR INDICATED THE SAMPLE PROBE WAS DAMAGED AND DETERMINED THE PROBE AS THE LIKELY CAUSE FOR THE CUSTOMER ISSUE. THERE HAVE BEEN NO ADDITIONAL DISCREPANT RESULTS REPORTED ON THIS ARCHITECT C16000 ANALYZER (SN: (B)(4)) SINCE THE SAMPLE PROBE WAS REPLACED. INSTRUMENT OPERATIONS HAVE BEEN ACCEPTABLE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE AVAILABLE INFORMATION FROM THE CUSTOMER SITE AND FROM THE RESULTS OF THIS EVALUATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST A PRODUCT MALFUNCTION OCCURRED. THE ISSUE WAS ADDRESSED THROUGH STANDARD TROUBLESHOOTING PROCEDURES.
N
Patient 1
THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED; THEREFORE, THE DEVICE WAS NOT PERFORMING AS INTENDED AND THE EVALUATION CODES WERE CORRECTED.