MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2013-11-01 for ARCHITECT C8000 SYSTEM 01G06-11 manufactured by Abbott Manufacturing Inc.
[15932592]
The customer stated that the architect analyzer generated a higher than expected result of 7. 4 mmol/l for the potassium assay from one patient sample. A new sample from the same patient was then tested with a non-abbott device and a result of 4. 3 mmol/l was obtained with no impact to the patient overall health.
Patient Sequence No: 1, Text Type: D, B5
[15948220]
This report references report number 1628664-2013-00284 which was initially submitted against the cc creatinine assay and the evaluation results for the discrepant creatinine results will be submitted through a follow-up report to mdr number 1628664-2013-00284. The current mdr (1628664-2013-00298) is being submitted against a newly identified suspect device to address the discrepant potassium results generated from the same patient and previously reported under mdr number 1628664-2013-00284 the discrepant potassium results issue will be investigated under this current mdr 1628664-2013-00298. Product evaluation is in process and the results will be submitted in a follow-up report
Patient Sequence No: 1, Text Type: N, H10
[26399508]
Product evaluation was performed in order to investigate the issue. The complaint indicates a single sample tested on architect (b)(4) generated a discrepant high k result of 7. 4 mmol/l and when the sample was re-tested on a roche c6000 system the result was normal, 4. 3 mmol/l. The sample was not retested on (b)(4). No other samples or assay results are implicated. No instrument troubleshooting was performed and the service history does not include additional reports of discrepant k results. A review of c8000 and ict module tracking and trending did not identify any adverse trends related to erratic and/or elevated ict k results. The architect system operations manual provides adequate information related to handling specimens and consumables, required maintenance, and troubleshooting the reported issue. Based on the available information a singular definitive cause of the discrepant high k results was not identified. An issue with the suspect sample integrity could not be ruled out. The issue was isolated to a single sample. The available information does not reasonably suggest that a device malfunction caused the discrepant high k result. Based on the investigation results, a deficiency is not identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2013-00298 |
| MDR Report Key | 3442894 |
| Report Source | 01 |
| Date Received | 2013-11-01 |
| Date of Report | 2013-10-25 |
| Date Mfgr Received | 2013-12-17 |
| Device Manufacturer Date | 2009-11-01 |
| Date Added to Maude | 2014-01-31 |
| 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 | 2013-11-01 |
| 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 | 2013-11-01 |