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 2016-05-24 for ARCHITECT C16000 SYSTEM 03L77-01 manufactured by Abbott Manufacturing Inc.
[45858296]
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
[45858297]
The customer observed falsely elevated lithium results on the architect c16000 analyzer. The following data was provided sid (b)(4) initial 2. 252, repeat 0. 675, 0. 699 mmol/l. There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[47337732]
Additional data was provided on (b)(6) 2016. An evaluation is still in process. A follow up report will be submitted when the evaluation is complete. (b)(4). An evaluation is still in process.
Patient Sequence No: 1, Text Type: N, H10
[47337733]
On (b)(6) 2016, the customer observed additional falsely elevated lithium results on the architect c16000 analyzer. The following data was provided: (b)(6). There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[48932797]
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and instrument service. No adverse trend was identified for the customer's issue. Labeling was reviewed and found to be adequate. The issue was resolved through standard troubleshooting procedure, the field service representative replaced the worn out tubing, r1a pipettor inner (rohs) and adjusted the reagent/mixer cup flow rates. Based on all available information and abbott diagnostics' complaint investigation, the analyzer performed as intended and no product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
[73920900]
The device evaluation was reassessed and concluded that a malfunction of the tubing, r1a pipettor inner (rohs) was identified, therefore, the device was not performing as intended, however, no systemic issue or product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2016-00128 |
| MDR Report Key | 5676851 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-05-24 |
| Date of Report | 2017-04-14 |
| Date Mfgr Received | 2017-04-13 |
| Date Added to Maude | 2016-05-24 |
| 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 | NDW |
| Date Received | 2016-05-24 |
| Catalog Number | 03L77-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-05-24 |
| Catalog Number | 03L77-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-05-24 |