N
Patient 1
(B)(4). THIS EVENT OCCURRED IN (B)(6).
MAUDE MDR 6500059
- MDR report key
- 6500059
- Report number
- 1823260-2017-00805
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-03-28
- Date received
- 2017-04-18
- Adverse event
- 0
- 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 | COBAS 8000 C 502 MODULE | CLINICAL CHEMISTRY ANALYZER | ROCHE DIAGNOSTICS | JGQ | C502 | 05964067001 | NA | R | Y | |||
| 1 | COBAS 8000 C 502 MODULE | CLINICAL CHEMISTRY ANALYZER | ROCHE DIAGNOSTICS | JJE | C502 | 05964067001 | NA | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-04-18 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER RECEIVED A QUESTIONABLE TPUC3 TOTAL PROTEIN URINE/CSF GEN.3 RESULT FOR ONE PATIENT URINE SAMPLE. THE INITIAL RESULT BY A QUALITATIVE METHOD WAS NEGATIVE. NO SPECIFIC RESULT DATA WAS PROVIDED. THE SAME SPECIMEN WAS TESTED ON THE COBAS 8000 C 502 MODULE AND THE RESULTS WERE 111 MG/DL AND 109 MG/DL. THE CUSTOMER DID NOT KNOW WHICH RESULT WAS CORRECT. INFORMATION CONCERNING IF ANY ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY WAS REQUESTED, BUT IT WAS NOT PROVIDED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 189251. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED.
N
Patient 1
REVIEW OF THE PROVIDED REACTION KINETICS CONFIRMED THERE WAS A DIRECT INTERFERENCE DUE TO THE TURBIDITY OF THE SAMPLE. ON (B)(6) 2017, THE PATIENT HAD ANOTHER SAMPLE TESTED AND THE RESULT WAS 109 MG/L. THE SAMPLE WAS RETESTED BY A REAGENT MANUFACTURED BY (B)(4) AND THE RESULT WAS 14 MG/L.
N
Patient 1
THE ANALYZER WAS CHECKED AND NO PROBLEM WAS FOUND WITH THE SAMPLE OR REAGENT PROBES. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PHYSICIAN HAD SUSPECTED THE REPORTED RESULT. THE METHOD USED FOR THE QUALITATIVE TESTING WAS "ARKRAY AUTION ELEVEN AUTION STICKS 10EA".
N
Patient 1
ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT SPECIMEN DID NOT INCLUDE BENCE-JONES PROTEIN OR "OTHER M PROTEINS". THE MEDICATIONS TAKEN BY THE PATIENT WERE REVIEWED AND ONLY SALAZOSULFAPYRIDINE WAS A POTENTIAL INTERFERENCE AS IT IS COMPARABLE TO PHENAZOPYRIDINE WHICH INTERFERES WITH THE ASSAY AT A CONCENTRATION OF 300 MG/L. THE OTHER DRUGS ADMINISTERED TO THE PATIENT WERE NOT BELIEVED TO INTERFERE.
N
Patient 1
A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. THE TURBIDITY OF THE SAMPLE OR OTHER DISCOLORATION WERE THE MOST LIKELY ROOT CAUSES. A DRUG INTERFERENCE WAS EXCLUDED.