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 2010-09-29 for TETRAPHENYL BORATE, COLORIMETRY, POTASSIUM 11208764203 manufactured by Roche Diagnostics.
[1373147]
The customer received questionable potassium results and provided results for three patient samples. Two of the patients had discrepant potassium results. Patient 1, initial result was 2. 31 mmol/l, the first repeat gave 3. 69 mmol/l. The same sample repeated again at an external laboratory gave 3. 69 mmol/l. Patient 2, initial result was 3. 35 mmol/l, the first repeat gave 4. 12 mmol/l. The same sample repeated again at an external laboratory gave 4. 00 mmol/l. It is unknown which results were reported outside the laboratory. No adverse events have been alleged regarding the discrepancies. The issue was resolved when the customer began using a new lot of potassium strips. The analyzer used for testing was a reflotron iv instrument, (b)(4). Customer returned strips and relevant retention materials were tested. No abnormalities were identified. The differences could not be confirmed.
Patient Sequence No: 1, Text Type: D, B5
[8757433]
Clarification of response: it is unknown if the initial reporter sent a report to the fda. This event occurred in (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-05766 |
| MDR Report Key | 1847583 |
| Report Source | 01,05,06 |
| Date Received | 2010-09-29 |
| Date of Report | 2010-09-29 |
| Date of Event | 2010-03-24 |
| Date Mfgr Received | 2010-03-25 |
| Date Added to Maude | 2010-11-08 |
| 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 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 118 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68300 |
| Manufacturer Postal Code | 68300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TETRAPHENYL BORATE, COLORIMETRY, POTASSIUM |
| Generic Name | REFLOTRON POTASSIUM TEST TABS |
| Product Code | CEJ |
| Date Received | 2010-09-29 |
| Model Number | NA |
| Catalog Number | 11208764203 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN NA US NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-29 |