MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-06-30 for CALCIUM GEN. 2 05061482190 manufactured by Roche Diagnostics.
[4649779]
The customer had loaded a new calcium gen. 2 reagent pack of the same lot already in use onto the cobas c501 analyzer serial number (b)(4). The customer did not perform qc on the reagent pack and began testing patient samples. The customer received questionable high results for 14 of the patient samples. The reagent pack in question was discarded and a new reagent pack of the same lot was loaded onto the analyzer and calibration and qc were performed which were acceptable. The patient samples were then retested. Data was only provided for one patient sample that had to be corrected. The initial result was 14. 0 mg/dl and was reported outside the laboratory. The repeat result was 9. 4 mg/dl and was believed to be correct. There was no adverse event. The customer found two discarded reagent packs in the garbage and noted one had a yellow substance around the top. The customer was not certain this was the reagent pack which generated the questionable results. The field service representative stated the calcium reagent pack appeared to be defective. He had the customer replace the reagent rack and run qc. The customer ran precision testing and felt everything was resolved.
Patient Sequence No: 1, Text Type: D, B5
[11929262]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[12156234]
A specific root cause could not be identified. As the reagent pack was discarded, no further root cause analysis was possible. The issue did not reoccur after using a new reagent cassette and the issue appears to have been resolved.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-04740 |
| MDR Report Key | 3901566 |
| Report Source | 05,06 |
| Date Received | 2014-06-30 |
| Date of Report | 2014-07-17 |
| Date of Event | 2014-06-19 |
| Date Mfgr Received | 2014-06-19 |
| Date Added to Maude | 2014-06-30 |
| 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 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 | CALCIUM GEN. 2 |
| Generic Name | TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM |
| Product Code | CHW |
| Date Received | 2014-06-30 |
| Model Number | NA |
| Catalog Number | 05061482190 |
| Lot Number | 69747201 |
| ID Number | NA |
| Device Expiration Date | 2015-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2014-06-30 |