MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2007-03-27 for C8000 CALCIUM 7D61-20 manufactured by Abbott Manufacturing, Inc..
[723796]
The customer states that a female pt complaining of thirst with signs of dehydration and on calcium supplements generated an initial architect c8000 calcium assay result of 4. 4 mmol/l (17. 6 mg/dl). The sample was retested and generated a result of 4. 14 mmol/l (16. 56 mg/dl). The pt was hospitalized and blood was redrawn that generated a calcium result of 2. 4 mmol/l (9. 6 mg/dl). The initial sample was then retested and generated a result of 2. 14 mmol/l (8. 56 mg/dl). The customer states that, the initial sample arrived at their lab late on a friday, was centrifuged and stored at 4 degrees centigrade on gel over the week-end. The sample was tested the following monday morning. Controls were within specs. The pt was released from the hospital with no further impact to pt mgmt reported.
Patient Sequence No: 1, Text Type: D, B5
[8007181]
This is an initial report. A final report will be submitted at the conclusion of an investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2018433-2007-00005 |
| MDR Report Key | 924218 |
| Report Source | 01,05,06 |
| Date Received | 2007-03-27 |
| Date of Report | 2007-03-06 |
| Date of Event | 2007-02-26 |
| Date Mfgr Received | 2007-03-06 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2007-10-10 |
| 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 BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK RD. |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| 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 | JFO |
| Date Received | 2007-03-27 |
| Model Number | NA |
| Catalog Number | 7D61-20 |
| Lot Number | 44064HW00 |
| ID Number | NA |
| Device Expiration Date | 2008-05-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 896352 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 820 MISSION ST. SOUTH PASADENA CA 91030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-03-27 |