MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-05-14 for CALCIUM 03L79-31 manufactured by Abbott Manufacturing Inc.
[144981862]
All available patient information has been included. No additional patient information is available. An evaluation is in process. A follow up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[144981863]
The customer reported a false elevated calcium result when processing on the architect c16000. The initial result was 4. 2023 mmol/l and retest was 2. 2475 mmol/l. The customer uses a reference range of 2. 10-2. 55 mmol/l. An archived specimen (with an initial result of 3. 2538 mmol/l) was retested with consistent results as the retest result was 3. 2916 mmol/l. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2019-00376 |
| MDR Report Key | 8608163 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-05-14 |
| Date of Report | 2019-05-31 |
| Date Mfgr Received | 2019-05-24 |
| Device Manufacturer Date | 2018-06-12 |
| Date Added to Maude | 2019-05-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224667-512 |
| Manufacturer G1 | ABBOTT MANUFACTURING INC |
| Manufacturer Street | 1921 HURD DRIVE |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CALCIUM |
| Generic Name | CALCIUM |
| Product Code | CJY |
| Date Received | 2019-05-14 |
| Catalog Number | 03L79-31 |
| Lot Number | 32860UN18 |
| Device Expiration Date | 2019-05-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-14 |