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 2016-11-29 for ARCHITECT LACTIC ACID 09D89-21 manufactured by Abbott Manufacturing Inc.
[61085989]
Abbott laboratories identified negative interference from the drug n-acetyl cysteine (nac) with the architect lactic acid assay leading to falsely depressed lactic acid results. A product correction letter was issued to all current architect lactic acid customers. The letter informs the customer that patients undergoing treatment with n-acetyl cysteine (nac) may have falsely depressed lactic acid results. Architect lactic acid list number (b)(4) is being discontinued. Customers who receive the final lots of list number (b)(4) will be notified of the interference from nac via additional labeling (kit stuffer) contained within the reagent kit.
Patient Sequence No: 1, Text Type: N, H10
[61085990]
The customer performed n-acetyl cysteine (nac) interference testing with several architect chemistry assays in (b)(6) 2015 and discovered interference with the lactic acid assay. No discrepant architect patient results or impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2016-00291 |
| MDR Report Key | 6133121 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-11-29 |
| Date of Report | 2016-11-29 |
| Date of Event | 2015-11-20 |
| Date Mfgr Received | 2016-11-16 |
| Date Added to Maude | 2016-11-29 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 1628664-10/11/16-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT LACTIC ACID |
| Generic Name | LACTIC ACID |
| Product Code | KHP |
| Date Received | 2016-11-29 |
| Catalog Number | 09D89-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2016-11-29 |