MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-05 for ARCHITECT C4000 ANALYZER 02P24-40 manufactured by Abbott Manufacturing Inc.
[35357243]
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
[35357244]
The customer reports discrepant multigent clin chem ammonia results being generated for patient samples on an architect c4000 analyzer. Results for the patient 1 diagnosed with an amino acid disorder are summarized below: (b)(6). Patient 2: an initial sample generated a result of 88 ug/dl, which was reported from the lab. A previous sample from this patient generated a result of 39 ug/dl. Patient 3: an initial result of 21 ug/dl, retested at 21 ug/dl (the customer ran this sample to trouble shoot the issue and demonstrate reproducibility upon retesting). Controls have remained within specifications on all runs. No suspect results have been reported form the lab. The customer uses a normal reference range of 18 - 72 ug/dl. There is no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[35452799]
No returns were available from the customer site for this evaluation. A review was performed of the available data logs from the architect c4000 analyzer. No determination could be made as to any system related cause for the current customer issue. The service history for this analyzer does not include a recurrence of inconsistent or erratic ammonia results or any information applicable to the current complaint. The customer opened a new reagent pack of the same lot and recalibrated the assay and sample pipettor along with collecting new patient samples during troubleshooting, which resolved the customer issue. The architect system operations manual and the multigent ultra ammonia assay package insert contain information to address the current customer issue. A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation. Based on the available information from the customer site and from the results of this evaluation, there is no evidence to reasonably suggest a product malfunction occurred. The issue was addressed through standard troubleshooting procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2016-00001 |
| MDR Report Key | 5344441 |
| Date Received | 2016-01-05 |
| Date of Report | 2016-01-08 |
| Date of Event | 2015-12-12 |
| Date Mfgr Received | 2016-01-08 |
| Device Manufacturer Date | 2011-06-01 |
| Date Added to Maude | 2016-01-05 |
| 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 C4000 ANALYZER |
| Generic Name | AUTOMATED CHEMISTRY ANALYZER |
| Product Code | JIF |
| Date Received | 2016-01-05 |
| Catalog Number | 02P24-40 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-05 |