MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-07-01 for CLINICAL CHEMISTRY CALCIUM 03L79-21 manufactured by Abbott Manufacturing Inc.
[112844453]
All available patient information was included. Additional patient details are not available. An evaluation is in process. A final report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[112844454]
The customer observed a falsely elevated calcium result on the architect c16000 analyzer. The following data was provided: sid (b)(6) initial 15. 8, repeats 9. 4, 9. 4 mg/dl. There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[120730304]
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of field data, review of labeling and instrument service. No adverse trend was identified for the customer's issue. No return patient sample was available. Historical performance of the reagent lot was evaluated using world wide data. The patient data was analyzed and within established control limits. Labeling was reviewed and found to be adequate. The architect tubing peristaltic head (rohs) (b)(4) was replaced, which resolved the issue. Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2018-00262 |
| MDR Report Key | 7654097 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-07-01 |
| Date of Report | 2018-09-11 |
| Date of Event | 2018-06-22 |
| Date Mfgr Received | 2018-09-07 |
| Device Manufacturer Date | 2018-01-30 |
| Date Added to Maude | 2018-07-01 |
| 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 | CLINICAL CHEMISTRY CALCIUM |
| Generic Name | CALCIUM |
| Product Code | CJY |
| Date Received | 2018-07-01 |
| Catalog Number | 03L79-21 |
| Lot Number | 06849UN17 |
| Device Expiration Date | 2019-01-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-07-01 |