MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-03-28 for ARCHITECT C8000 SYSTEM 01G06-01 manufactured by Abbott Manufacturing Inc.
[2595268]
The customer stated a discrepant low phenytoin result was generated on the architect c8000 analyzer. The initial result was 31. 5 mg/dl and was repeated due to being a panic value. The repeat result was 6. 9 mg/dl. The sample was retested with a result of >40 mg/dl, and upon dilution, was 33. 5 mg/dl. The low value was suspected to be incorrect and the initial result of 31. 5 mg/dl was reported. The patient's previous phenytoin results have been in the panic range. There was no report of impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[9724964]
(b)(4); no consequences or impact to patient (b)(4); low test results. 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
[9855958]
After further evaluation, the suspect medical device was changed from the architect phenytoin reagent, list # 01e07-20 to the architect c8000 analyzer, list # 01g06-01. Field service performed preventive and quarterly maintenance and replaced and calibrated the reagent 2 probe. Although precision was confirmed to be acceptable by testing a qc sample, the customer continued to have poor precision. The reagent 1 probe was replaced to resolve the issue. The architect system operations manual lists multiple probable causes and corrective actions for erratic results. Categories for probable causes include reagent probe is partially obstructed or damaged and protein buildup inside the probe. A review of quality metrics, customer complaints and instrument service history did not identify any adverse trends for the reagent probe. Based upon the data available and the results of this evaluation no product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2012-00191 |
| MDR Report Key | 2508077 |
| Report Source | 05 |
| Date Received | 2012-03-28 |
| Date of Report | 2012-03-08 |
| Date of Event | 2012-03-04 |
| Date Mfgr Received | 2012-03-30 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2012-06-06 |
| 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 | DKH |
| Date Received | 2012-03-28 |
| Catalog Number | 01G06-01 |
| Lot Number | 44897UN11 |
| 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 | 2012-03-28 |