MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-06-27 for COBAS INTEGRA PHOSPHORUS 2 03183793122 manufactured by Roche Diagnostics.
[2070393]
The user received a questionable phosphorus result for one patient sample from the integra 800 serial number (b)(4). The issue was discovered when samples tested (b)(6) 2011 through (b)(6) 2011 were repeated due to a physician questioning a patient result. The initial result was 5. 1 mg/dl and was reported outside the laboratory. The sample was repeated on (b)(6) 2011 on another integra 800 analyzer at the site and the result was 6. 9 mg/dl. The patient was not treated on the basis of the original reported result and suffered no adverse consequences from this incident. The phosphorus reagent lot in use at the time of the repeat testing was 63820201. Upon evaluation of the analyzer, the field service representative determined there was a break in the liquid level sense cable and replaced it. He also replaced broken probe holders as a precaution. To verify the analyzer operation, he ran performance testing.
Patient Sequence No: 1, Text Type: D, B5
[9201100]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-03469 |
| MDR Report Key | 2141559 |
| Report Source | 05,06 |
| Date Received | 2011-06-27 |
| Date of Report | 2011-06-27 |
| Date of Event | 2011-06-04 |
| Date Mfgr Received | 2011-06-10 |
| Date Added to Maude | 2011-06-27 |
| 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 JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 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 | COBAS INTEGRA PHOSPHORUS 2 |
| Generic Name | PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS |
| Product Code | CEO |
| Date Received | 2011-06-27 |
| Model Number | NA |
| Catalog Number | 03183793122 |
| Lot Number | 63417501 |
| ID Number | NA |
| Device Expiration Date | 2012-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9118 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-27 |