MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-11-15 for ARCHITECT C16000 SYSTEM 03L77-01 manufactured by Abbott Manufacturing Inc.
[17447452]
The customer observed a falsely elevated potassium result for one patient on the architect c16000 analyzer. The following data was provided: patient 2 initial 6. 3, retest 4. 5 mmol/l. There was no impact to patient management reported. The syringe seal tip, pipetor inner tubing, sample probe, reagent probe, reagent probe tubing, and sample probe tubing was all inspected and replaced on the architect. This resolved the issue. The customer has not seen any further erratic data.
Patient Sequence No: 1, Text Type: D, B5
[17755082]
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
| Report Number | 1628664-2013-00334 |
| MDR Report Key | 3471488 |
| Report Source | 01,05 |
| Date Received | 2013-11-15 |
| Date of Report | 2013-10-25 |
| Date of Event | 2013-10-25 |
| Date Mfgr Received | 2013-10-25 |
| Date Added to Maude | 2014-02-24 |
| 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 C16000 SYSTEM |
| Product Code | MZV |
| Date Received | 2013-11-15 |
| Catalog Number | 03L77-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2013-11-15 |