MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-10-11 for C8000 CALCIUM 7D61-20 manufactured by Abbott Manufacturing, Inc.
[16517937]
Pt sample was discarded by the account and is unavailable for return. No instrument causes for the erroneous calcium result are apparent. No reagent cause for the erroneous result is apparent. The qc was stable with no apparent trends or shifts in calcium recovery. Other results generated by the sys are accurate including several panic valves that were rechecked and verified. The customer suspects fibrin was responsible, as there was no manual check for it prior to assaying the sample. The instrument and reagent documentation advise the customer that fibrin, bubbles or particulate matter may interfere with the assay and cause erroneous results. Fibrin may prevent an adequate amount of sample from being aspirated or dispensed into the cuvette. In addition, the instrument logs have been requested from the customer. An examination of these logs will be performed before any final conclusions are drawn. A final report will be submitted at the completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[16637337]
The customer stated that the architect c8000 generated a low calcium result of 2. 8 mg/dl with reagent lot # 13053hw00. The sample was repeated two times with results of 7. 4 mg/dl. The customer stated that they did not check the sample for fibrin prior to running it the first time, but stated no fibrin was present after the initial run. The customer stated that they had no other instances of erratic results. The customer felt the issue was due to fibrin in the sample and have asked their techs to monitor the samples closely for fibrin. There was no impact to pt mgmt as the result was not reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2018433-2004-00002 |
| MDR Report Key | 905470 |
| Report Source | 06 |
| Date Received | 2004-10-11 |
| Date of Report | 2004-10-07 |
| Date Mfgr Received | 2004-09-08 |
| Device Manufacturer Date | 2004-01-01 |
| Date Added to Maude | 2007-08-31 |
| 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 | 0 |
| Manufacturer Contact | DR DAVID SPINDELL |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479351869 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C8000 CALCIUM |
| Generic Name | CALCIUM |
| Product Code | JFP |
| Date Received | 2004-10-11 |
| Model Number | NA |
| Catalog Number | 7D61-20 |
| Lot Number | 13053HW00 |
| ID Number | NA |
| Device Expiration Date | 2005-11-10 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 880298 |
| Manufacturer | ABBOTT MANUFACTURING, INC |
| Manufacturer Address | 820 MISSION ST. SOUTH PASADENA CA 91030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-10-11 |