MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-09-27 for ARCHITECT C8000 SYSTEM 01G06-11 manufactured by Abbott Manufacturing Inc.
[89417812]
A review of tickets did not identify an increase in complaints related to falsely elevated potassium (k) results and no trends for the customer's reported issue for the ict diluent, lot 60311un17. Return testing was not completed as returns were not available. The customer reported that the sample was not hemolyzed. A review of labeling was found to adequately advise the customer on ict sample analyses including: sample preparation, troubleshooting and resolution of results related issues. The architect c803168 logs were reviewed and multiple error code 3375 [aspiration errors] were noted to have occurred close to the suspect potassium results. Error code 3375 is generated by the instrument when an aspiration error occurs on a sample, suggesting that the sample was insufficiently prepared prior to analysis. Based on sample calculations performed by the instrument during measurement, the ict reference solution measurements before and after the suspect sample potassium measurement, are stable. The sample shows a higher than expected sample read voltage. Based on the complaint data and this investigation, no product deficiency was identified for ict diluent, lot 60311un17 or the architect c803168 analyzer.
Patient Sequence No: 1, Text Type: N, H10
[89417813]
The customer reported a falsely elevated potassium (k) result on one patient. The results provided were: initial 6. 5/ repeated = 4 and 4 / run 10x = 4 mmol/l. There was no reported impact to patient management. There was no additional patient information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2017-00360 |
| MDR Report Key | 6897709 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-09-27 |
| Date of Report | 2017-09-27 |
| Date of Event | 2017-09-14 |
| Date Mfgr Received | 2017-09-14 |
| Device Manufacturer Date | 2010-02-01 |
| Date Added to Maude | 2017-09-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | CEM |
| Date Received | 2017-09-27 |
| Catalog Number | 01G06-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Brand Name | ARCHITECT C8000 SYSTEM |
| Generic Name | AUTOMATED CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-09-27 |
| Catalog Number | 01G06-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-09-27 |