N
Patient 1
THIS EVENT OCCURRED IN (B)(6). (B)(4).
MAUDE MDR 7071328
- MDR report key
- 7071328
- Report number
- 1823260-2017-02792
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-11-10
- Date received
- 2017-11-30
- 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
- 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | GLUC3 GLUCOSE HK GEN.3 | HEXOKINASE, GLUCOSE | ROCHE DIAGNOSTICS | CFR | NA | 04404483190 | 281302 | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-11-30 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT TESTED FOR GLUC3 GLUCOSE HK (GLUC3) ON 2 COBAS 6000 C (501) MODULES USED IN THE BIOCHEMISTRY LABORATORY OF THE HOSPITAL. TWO SAMPLE TUBES WERE DRAWN AT THE SAME TIME AND TESTED ON BOTH OF THE CUSTOMER?S C501 MODULES WITH RESULTS OF EITHER