MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2010-04-29 for REFLOTRON POTASSIUM TEST TABS 11208764202 manufactured by Na.
[15560202]
Complainant alleged that during a routine shift check by a clinician, the device failed to discharge. Complainant indicated that there was no pt involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
[15887239]
Differences between plasma and serum potassium values, which exceeded 0. 8 mmol/l, could not be verified. No malfuction was detected. Both of the patient's potassium values were below the respective reference ranges for the sample material. A potassium substitution would have been considered with either value.
Patient Sequence No: 1, Text Type: N, H10
[21781117]
Customer had a heparin plasma sample and a serum sample drawn at the same time from one patient. The potassium results from the two samples were discrepant. Plasma sample potassium results were 2. 79 and 2. 86, no units of measure provided. Serum sample potassium results were 3. 58 and 3. 50, no units of measure provided. No information was provided to determine which results were reported or if patient was affected. No adverse events were reported. Potassium reagent lot was 23761233. Investigation is on-going.
Patient Sequence No: 1, Text Type: D, B5
[21830643]
Expiration date of reflotron potassium test tabs was not provided. It is unknown if initial reporter sent report to fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-02553 |
| MDR Report Key | 1670044 |
| Report Source | 01,05,06 |
| Date Received | 2010-04-29 |
| Date of Report | 2010-06-09 |
| Date of Event | 2010-04-06 |
| Date Mfgr Received | 2010-04-06 |
| Date Added to Maude | 2010-06-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| Manufacturer G1 | NA |
| Manufacturer Street | NA NA |
| Manufacturer City | NA NA |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REFLOTRON POTASSIUM TEST TABS |
| Generic Name | POTASSIUM TEST SYSTEM |
| Product Code | CEJ |
| Date Received | 2010-04-29 |
| Returned To Mfg | 2010-04-13 |
| Model Number | NA |
| Catalog Number | 11208764202 |
| Lot Number | 23761230 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NA |
| Manufacturer Address | NA NA NA NA NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-29 |