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 2017-04-05 for ACTIVATED ALANINE AMINOTRANSFERASE 08L92-41 manufactured by Abbott Manufacturing Inc.
[71734182]
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
[71734183]
The customer stated that the architect analyzer is generating falsely elevated alt results on a liver transplant patient. The results provided were from two samples (same patient) tested on different analyzers: (b)(6) 2017 on c2 analyzer (b)(6) - alt = 16 / on c3 (sn (b)(4)) (b)(6) - alt = 86. No additional patient information was provided.
Patient Sequence No: 1, Text Type: D, B5
[74188162]
After further evaluation, the suspect medical device was changed from activated alanine aminotransferase, list number 08l92-41, manufacturing site: abbott manufacturing inc, (b)(4) in this report to architect c16000 system; list number 03l77-01; manufacturing site: abbott manufacturing inc, (b)(4). Mdr number 1628664-2017-00122 has been submitted and all further information will be documented under that mdr number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2017-00090 |
| MDR Report Key | 6460302 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-04-05 |
| Date of Report | 2017-04-21 |
| Date of Event | 2017-03-14 |
| Date Mfgr Received | 2017-04-03 |
| Date Added to Maude | 2017-04-05 |
| 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 |
| 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 | ACTIVATED ALANINE AMINOTRANSFERASE |
| Generic Name | ALANINE AMINOTRANSFERASE (ALT) IVD, REAGENT |
| Product Code | CKA |
| Date Received | 2017-04-05 |
| Catalog Number | 08L92-41 |
| Lot Number | 62964UN16 |
| Device Expiration Date | 2017-08-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Other | 2017-04-05 |