ARCHITECT B12 REAGENT KIT
Report
- Report Number
- 3005094123-2022-00005
- Event Type
- Malfunction
- Date Received
- January 6, 2022
- Date of Event
- August 2, 2021
- Report Date
- March 22, 2022
- Manufacturer
- A.I.D.D LONGFORD
- Product Code
- CDD
- UDI-DI
- 00380740014193
- PMA / PMN Number
- K121314
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED TO ARCHITECT I2000SR, LIST 3M74 (IRVING, TX AS MANUFACTURING SITE) AND SUBMITTED UNDER MANUFACTURER REPORT NUMBER 3016438761-2022-00047-01. ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER MDR NUMBER 3016438761-2022-00047-01.
THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT B12 RESULT ON A PATIENT. RESULTS PROVIDED: (B)(6) 2021, SID (B)(6)= 364 PG/ML< REPEATED ON (B)(6) 2021 = 274 PG/ML (BOTH RESULTS USING LOT# 23108UI00). NORMAL RANGE: 345-1485 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT B12 RESULT ON A PATIENT. RESULTS PROVIDED: (B)(6) 2021, SID (B)(6)= 364 PG/ML< REPEATED ON (B)(6) 2021 = 274 PG/ML (BOTH RESULTS USING LOT# 23108UI00). NORMAL RANGE: 345-1485 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 51539 | ARCHITECT B12 REAGENT KIT | RADIOASSAY, VITAMIN B12 | CDD | A.I.D.D LONGFORD | 7K61-37 | 23108UI00 | 00380740014193 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | ARC I2000SR INST, 03M74-02, ISR61701| ARC I2000SR INST, 03M74-02, ISR61701 |