MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-12-19 for CALCIUM GEN. 2 05061482190 manufactured by Roche Diagnostics.
[11615838]
Additional information for further investigation was requested but not provided. A root cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[21266367]
The customer received questionable results for calcium gen. 2 (ca) on three patient samples. Of those three, it was determined that one sample had erroneous results that were reported outside of the laboratory. The patient had an initial ca result of 6. 2 mg/dl; which was considered critical by the customer and was reported to the "er" physician, who questioned the result. The sample was repeated on the same instrument and generated a repeat result of 8. 6 mg/dl. The customer deemed the repeat result to be the correct result and called it to the physician. There was no effect to the patient, and there was no adverse event. The testing was performed on a cobas 6000 c501 analyzer with serial number (b)(4). On further follow up, the customer indicated they resolved the issue by replacing the reagent pack. The customer refused a service dispatch for the issue.
Patient Sequence No: 1, Text Type: D, B5
[21576990]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-07780 |
| MDR Report Key | 3528554 |
| Report Source | 05,06 |
| Date Received | 2013-12-19 |
| Date of Report | 2014-03-24 |
| Date of Event | 2013-12-12 |
| Date Mfgr Received | 2013-12-12 |
| Date Added to Maude | 2013-12-19 |
| 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) 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 | CALCIUM GEN. 2 |
| Generic Name | TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM |
| Product Code | CHW |
| Date Received | 2013-12-19 |
| Model Number | NA |
| Catalog Number | 05061482190 |
| Lot Number | 68826801 |
| ID Number | NA |
| Device Expiration Date | 2014-08-31 |
| 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 | 2013-12-19 |