D
Patient 1
CUSTOMER REPORTED NEGATIVE NITRITE AND LEUKOCYTES RESULTS ON THE INSTRUMENT WHEREAS CULTURE RESULTS WERE POSITIVE FOR BOTH ANALYTES. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.
MAUDE MDR 3649068
- MDR report key
- 3649068
- Report number
- 1217157-2014-00020
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-01-15
- Date received
- 2014-02-14
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- STEVEN ANDBERG
- Address
- 2 EDGEWATER DR. NORWOOD MA 02062 US
- Phone
- 781-781-7812
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MULTISTIX 10SG STRIPS | MULTISTIX 10SG | SIEMENS HEALTHCARE DIAGNOSTICS INC. | JIO | 10627148 | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-02-14 | 0 |
Event Narratives#
N
Patient 1
CUSTOMER IS BEING REQUESTED TO SEND REAGENT BACK FOR FURTHER INVESTIGATION. CUSTOMER INDICATED THAT THEY ARE NOT CURRENTLY USING SIEMENS TEST STRIPS. THE CAUSE FOR THE DISCORDANT RESULTS IS UNKNOWN.
N
Patient 1
THE INITIAL MDR 1217157-2014-00020 WAS FILED WITH FDA ON FEBRUARY 14, 2014. ADDITIONAL INFORMATION: BASED ON THE ADDITIONAL INFORMATION, SIEMENS TECHNICAL OPERATIONS TESTED CUSTOMER'S RETURNED REAGENT AND COULD NOT CONFIRM COMPLAINT. AS PER THE MODERN URINE CHEMISTRY MANUAL, "A NEGATIVE NITRITE SHOULD NEVER BE INTERPRETED AS INDICATING AN ABSENCE OF BACTERIURIA. THERE ARE SEVERAL REASONS FOR THIS. FIRST-MORNING URINE, OR URINE THAT HAS REMAINED IN THE BLADDER FOR FOUR OR MORE HOURS, IS MOR LIKELY TO YIELD A POSITIVE NITRITE TEST RESULT IN THE PRESENCE OF SIGNIFICANT BACTERIURIA THAN A RANDOM URINE SAMPLE THAT HAVE BEEN IN THE BLADDER ONLY A SHORT TIME. IN THE LATTER TYPE OF SPECIMEN, THERE MAY HAVE BEEN INSUFFICIENT TIME FOR THE CONVERSION OF NITRATE TO NITRITE BY THE INFECTING BACTERIA. SOME STRAINS OF URINARY PATHOGENS DO NOT PRODUCE THE ENZYME NECESSARY TO REDUCE NITRATE TO NITRITE, BUT THES ORGANISMS ARE THE LEAST COMMON PATHOGENS. A NEGATIVE TEST RESULT MAY ALSO OCCUR IF DIETARY NITRATES ARE ABSENT." CUSTOMER HAS BEEN PROVIDED WITH A REPLACEMENT BOTTLE OF REAGENT.