MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-09-20 for ARCHITECT C8000 SYSTEM 01G06-11 manufactured by Abbott Manufacturing Inc.
[22138995]
The customer observed a falsely elevated potassium result for one patient on the architect c8000 analyzer. The following data was provided: (b)(6) greater than 10, repeated greater than 10 mmol/l. The sample was decanted into a beaker; measured 4. 26 mmol/l, repeated 4. 26 mmol/l. The customer uses the normal range of 3. 5 to 5. 1 mmol/l. The controls and calibration was in range. The sample was clear, no hemolysis; the serum monovette was correctly filled. The sodium value from the first sample (prior to decanting into the beaker) was normal (131. 1 mmol/l). There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[22340667]
An evaluation is in process. A follow up report will be submitted when the evaluation is complete. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[26396315]
Further investigation of the customer issue included a review of historical and complaint data, a review of labeling, and review of the customer's logs. Review of the data did not identify any product issue or adverse trend. Labeling was reviewed and found to be adequate. The logs include numerous occurrences of error code 3375 unable to process test, aspiration error occurred, which supports sample integrity and/or handling as possible contributing factors. The logs also show 14 occurrences of error code 0550 (cuvette washing not completed, hardware failure or user pressed stop. Promptly perform the wash cuvettes procedure) between (b)(6). The corrective actions for error 0550 include performing as-needed maintenance procedure wash cuvettes, which resolved the customer's issue. Based on the results of this investigation, no malfunction or deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2013-00249 |
| MDR Report Key | 3360581 |
| Report Source | 01,05 |
| Date Received | 2013-09-20 |
| Date of Report | 2013-09-03 |
| Date of Event | 2013-09-02 |
| Date Mfgr Received | 2013-10-08 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2013-11-25 |
| 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 | MZV |
| Date Received | 2013-09-20 |
| Catalog Number | 01G06-11 |
| Operator | OTHER |
| 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 | 2013-09-20 |