N
Patient 1
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT PROBLEM CODE: NO CONSEQUENCES OR IMPACT TO (B)(4).
MAUDE MDR 5320260
- MDR report key
- 5320260
- Report number
- 3005094123-2015-00027
- Event key
- 0
- Event type
- 3
- Date received
- 2015-12-22
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ARCHITECT B12 | VITAMIN B12 | A.I.D.D LONGFORD | CDD | 07K61-37 | 52963UI00 | Y | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-12-22 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER REPORTS THAT ONE PATIENT SAMPLE GENERATED AN ARCHITECT VITAMIN B12 ASSAY RESULT OF 392 PG/ML WITH REAGENT LOT 52963UI00 ON AN ARCHITECT (B)(4) ANALYZER. THE ASSAY WAS RECALIBRATED USING REAGENT LOT 54925UI00 AND CALIBRATOR LOT 51246UI00 AND THE SAMPLE RETESTED, WHICH GENERATED A RESULT OF 299 PG/ML. THE ASSAY WAS AGAIN RECALIBRATED WITH REAGENT LOT 54925UI00 AND CALIBRATOR LOT 55261UI00 AND GENERATED A RESULT OF 311 PG/ML. THE CUSTOMER USES A NORMAL REFERENCE RANGE OF 200-900 PG/ML. THIS ISSUE WAS DISCOVERED WHEN THE LEVEL THREE CONTROL SAMPLE SHIFTED DOWN WITHIN SPECIFICATIONS WITH THE CALIBRATION OF REAGENT LOT 54925UI00 WITH CALIBRATOR LOT 51246UI00. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
N
Patient 1
THERE WERE NO RETURNS MADE AVAILABLE FROM THE CUSTOMER SITE FOR THIS EVALUATION. ACCURACY TESTING WAS PERFORMED USING IN-HOUSE RETAINED REAGENTS OF THE ARCHITECT B12 ASSAY, LIST (B)(4), LOT 52963UI00 WITH PANEL SAMPLES CONTAINING SPECIFIC AMOUNTS OF VITAMIN B12. ALL RESULTS MET SPECIFICATIONS, INDICATING ACCEPTABLE PERFORMANCE OF THIS REAGENT LOT. 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 B12 ASSAY PACKAGE INSERT AND THE ARCHITECT OPERATION MANUAL CONTAIN 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.