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 2017-03-08 for ARCHITECT C16000 SYSTEM 03L77-01 manufactured by Abbott Manufacturing Inc.
[69384321]
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
[69384322]
The customer stated the architect analyzer generated falsely elevated creatinine results on 2 patients. The results provided were: (b)(6) = creatinine 348 / 50 umol/l; (b)(6) = creatinine 323 / 72umol/l. There was no reported impact to patient management. There was no additional patient information provided.
Patient Sequence No: 1, Text Type: D, B5
[73132297]
Evaluation of the customer issue included a review of: the complaint text, service history, trend reports, complaint searches, and product labeling. The customer observed erratic results on several tests for multiple patient samples on architect c1600986. Upon a site visit, the field service engineer (fse) found the high concentration peristaltic pump tubing for the 1b probe leaking and the cuvettes were overflowing. The fse performed troubleshooting: cleaning the low concentration waste manifold and tank, replacing the cuvette dry tips, and replacing the peristaltic head tubing (rohs) (part number 7-202464-01). A review of the architect c1600986 service history identified no contributing factors on or around the date of the complaint. There have been no subsequent contacts from the customer regarding erratic or discrepant results since the peristaltic head tubing (rohs) was replaced. The architect system operations manual provides adequate information for troubleshooting erratic/discrepant results. The architect c16000 system service and support manual provides instructions for the removal, replacement and verification of the peristaltic head tubing (rohs). A search for similar complaints identified no adverse trend of peristaltic head tubing (rohs) in the past 12 months. A review of the architect c16000 tracking and trending revealed no systemic issues or trends associated with erratic results. A malfunction was identified for the peristaltic head tubing (rohs) (part number 7-202464-01) as the device failed to meet performance specifications or otherwise perform as intended at the customer site. No systemic issue or product deficiency was identified for the part or the architect c16000.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2017-00061 |
| MDR Report Key | 6387462 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-03-08 |
| Date of Report | 2017-04-05 |
| Date of Event | 2017-02-03 |
| Date Mfgr Received | 2017-04-05 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2017-03-08 |
| 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 C16000 SYSTEM |
| Generic Name | AUTOMATED CHEMISTRY ANALYZER |
| Product Code | JGX |
| Date Received | 2017-03-08 |
| Catalog Number | 03L77-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| 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 C16000 SYSTEM |
| Generic Name | AUTOMATED CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-03-08 |
| Catalog Number | 03L77-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2017-03-08 |