MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,foreign,health profe report with the FDA on 2015-05-06 for PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS 11730347216 manufactured by Roche Diagnostics.
[5827616]
The customer questioned inorganic phosphorus (phos) results for an unknown number of patient samples. The customer is questioning phos results between reagent lot 60023601 and reagent lot 61065701. The samples were run at the customer site using both lot numbers and also at 2 different sites with lot 61065701. Of the data provided for 49 patient samples, 21 were erroneous. The erroneous results were reported outside of the laboratory. The initial phos tests were run at the customer site on (b)(6) 2015 with reagent lot 60023601. These results were reported outside of the laboratory. The physician called and indicated that the results were not what he expected to see. The samples were repeated on (b)(6) 2015 at the customer site and 2 other sites using reagent lot 61065701. The repeat results using the 2nd reagent lot were consistent with what the physician expected to see. No adverse event occurred. The analytical p module serial number was (b)(4). Water system maintenance was performed on (b)(6) 2015. The field service engineer checked multiple parts of the instrument and could not locate any issues. The vacuum pump was replaced.
Patient Sequence No: 1, Text Type: D, B5
[13430336]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[27065036]
Calibration and quality controls were acceptable. A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. The most likely root cause is related to pre-analytics or an issue specific to each sample (e. G. Drug interference).
Patient Sequence No: 1, Text Type: N, H10
[28346878]
It was noted that during a service visit, contaminated probes were identified due to insufficient flushing inside the nozzle. After replacing the valves, replacing the tubing and removing the washes probe, no additional phos discrepancies occurred.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03416 |
| MDR Report Key | 4752903 |
| Report Source | 01,05,06,FOREIGN,HEALTH PROFE |
| Date Received | 2015-05-06 |
| Date of Report | 2015-10-06 |
| Date of Event | 2015-04-08 |
| Date Mfgr Received | 2015-04-10 |
| Date Added to Maude | 2015-05-06 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS |
| Generic Name | PHOSPHORUS (INORGANIC) TEST SYSTEM |
| Product Code | CEO |
| Date Received | 2015-05-06 |
| Model Number | NA |
| Catalog Number | 11730347216 |
| Lot Number | 60023601 |
| ID Number | NA |
| Device Expiration Date | 2015-09-30 |
| Operator | HEALTH PROFESSIONAL |
| 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 NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-06 |