MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2013-07-29 for ARCHITECT C8000 SYSTEM 01G06-01 manufactured by Abbott Manufacturing Inc.
[3670616]
The customer stated an architect c8000 analyzer generated a falsely elevated lithium result for one patient sample. The architect generated an initial lithium result of 2. 4 and a repeat lithium result of 0. 8 mmol/l. A second sample was drawn from the patient and lithium results of 0. 8, 1. 5, 1. 5, 0. 83, 0. 88, 0. 78, and 0. 80 mmol/l were generated. There was no adverse impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[10912084]
(b)(4). A follow up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[11022734]
Further investigation of the customer's issue included a review of the complaint text, a search for similar complaints, and a review of labeling. The customer replaced the probe tubing and the reagent probe to resolve the issue. Tracking and trending did not identify any adverse trend for the customer's issue. Labeling was reviewed and found to be adequate. A product deficiency was not identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2013-00186 |
| MDR Report Key | 3252268 |
| Report Source | 01 |
| Date Received | 2013-07-29 |
| Date of Report | 2013-07-19 |
| Date Mfgr Received | 2013-08-21 |
| Device Manufacturer Date | 2006-11-01 |
| Date Added to Maude | 2013-10-23 |
| 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 | 0 |
| 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 | 847937-512 |
| 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 | ARCHITECT C8000 SYSTEM |
| Product Code | JIH |
| Date Received | 2013-07-29 |
| Catalog Number | 01G06-01 |
| 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 | 2013-07-29 |