MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-02 for ARCHITECT C8000 SYSTEM 01G06-01 manufactured by Abbott Manufacturing Inc.
[16085461]
The customer stated that the architect analyzer generated a falsely elevated potassium (k+) result on one patient sample. The results provided were: 6. 9 / 4. 5 (normal range 3. 4-4. 9). The customer verified that all maintenance is up-to-date. Ict module days on board = 57 with a status of exceeded. There was no reported impact to patient management. There was no additional patient information provided.
Patient Sequence No: 1, Text Type: D, B5
[16313109]
(b)(4). 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
[33597412]
Evaluation included a review of complaint text, service history, complaint and internal information, and a review of labeling. The customer reported that a falsely elevated potassium result was generated on the architectc8000 (serial number (b)(4)). The complaint text indicated no leaks were observed from the 1 ml syringes, sample syringes, or reagent syringes. A status of 'exceeded' was displayed for the ict module (serial number (b)(4)), which had been on-board for 57 days. A review of labeling shows probable causes and corrective actions relevant to the issue of erratic results or poor precision. A single definitive cause of the issue was not identified; multiple parts were replaced by field service and the customer replaced the ict module. Based on the available information, possible contributing factors for the elevated potassium results are reagent probe carryover of lactic acid and/or sample integrity. The lactic acid r1 reagent has a high concentration of potassium which may carryover if the r1 probe is worn, dirty, or damaged. There is insufficient information to reasonably suggest a device malfunction caused the result issue. Nor is there an indication of a deficiency of the architect c8000.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2014-00184 |
| MDR Report Key | 4050849 |
| Report Source | 05 |
| Date Received | 2014-09-02 |
| Date of Report | 2014-08-06 |
| Date of Event | 2014-08-06 |
| Date Mfgr Received | 2014-09-17 |
| Device Manufacturer Date | 2005-08-01 |
| Date Added to Maude | 2014-09-15 |
| 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 | 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 | ARCHITECT C8000 SYSTEM |
| Generic Name | AUTOMATED CHEMISTRY ANALYZER |
| Product Code | MZV |
| Date Received | 2014-09-02 |
| Catalog Number | 01G06-01 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2014-09-02 |