MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2010-09-22 for REFLOTRON POTASSIUM TEST TABS 11208764203 manufactured by Roche Diagnostics.
[1374233]
The customer received questionable potassium results when comparing two different potassium strip lot numbers. The instrument used for testing was a reflotron iv, (b)(4). The original potassium strip lot number alleged to produce questionable results was 23761332. The new potassium strip lot number was 23761534. The customer provided comparison results for six patient samples, one external control, and one internal control (run as a random sample). Results from one patient and the internal control were discrepant: the patient sample original potassium result using strip lot number 23761332 was 2. 41 mmol/l. The sample, repeated with strip lot number 23761534, gave 4. 75 mmol/l. The internal control original potassium result using strip lot number 23761332 was 2. 36 mmol/l. The control, repeated twice with strip lot number 23761534, gave 4. 32 mmol/l both times. All determinations were performed in the doctor's office. It is unknown which results were reported to a physician. No information about further actions taken by the physician were available. No adverse events were reported.
Patient Sequence No: 1, Text Type: D, B5
[8786906]
It is unknown if the initial reporter sent a report to the fda. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[21412717]
It was reported that during a da vinci si hysterectomy procedure, the site experienced system error #16. The site restarted the system and encountered system error #31030 on start up. To attempt to troubleshoot the issue, the site powered down the system, emergency powered off (epo's) the pt side cart (psc) and reset the breaker on all the components. The ends of the system cables were swapped between the console and psc; however, system error #31030 reoccurred. The surgeon decided to convert the procedure to traditional open surgical techniques to complete the planned procedure. No pt harm was reported.
Patient Sequence No: 1, Text Type: D, B5
[21477610]
The customer returned strips for investigation. Investigation of the returned customer strips and retention materials determined the strips performed as specified. The differences could not be confirmed. No malfunction was detected. No adverse event related to the device was reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-05613 |
| MDR Report Key | 1840628 |
| Report Source | * |
| Date Received | 2010-09-22 |
| Date of Report | 2010-12-02 |
| Date of Event | 2010-07-16 |
| Date Mfgr Received | 2010-08-11 |
| Date Added to Maude | 2010-12-02 |
| 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 | ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 118 |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68298 |
| Manufacturer Postal Code | 68298 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REFLOTRON POTASSIUM TEST TABS |
| Generic Name | TETRAPHENYL BORATE, COLORIMETRY, POTASSIUM |
| Product Code | CEJ |
| Date Received | 2010-09-22 |
| Catalog Number | 11208764203 |
| Lot Number | 23761332 |
| Operator | MEDICAL ASSISTANT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-22 |