MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2011-06-06 for CLINICAL CHEMISTRY AST-ACTIVATED 8L91-21 manufactured by Abbott Manufacturing Inc.
[2007770]
The customer stated that an architect activated ast result of <0. 08 u/l was generated on a female patient. The patient's activated alt result was 300 u/l. The activated ast result was repeated using a manual dilution which generated a very high result (exact value not provided). The customer suspects that substrate depletion occurred causing the initial result to be falsely low. The initial result was repeated because it did not align with the other laboratory results (elevated alt). During a follow-up conversation, the customer stated that the patient had died during surgery due to cardiac arrest. The initial low result was not reported out of the laboratory and there was no delay in treatment. The customer stated that the activated ast results did not cause or contribute to the patient death.
Patient Sequence No: 1, Text Type: D, B5
[8982532]
(b)(4). An investigation is in process. A follow-up report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[9381026]
The patient sample was available and was returned for investigation. Testing was also performed on the customer's returned patient serum sample with flex parameters. The patient sample did not generate a <5 u/l (<0. 08 ukat/l) result when run undiluted as observed by the customer. Undiluted and diluted 1:2 samples all gave either error code 1350 and 1351. When the sample was diluted 1:3, the result was >5364 u/l with a#2, >, and flex flags. Testing was performed to evaluate high activated aspartate aminotransferase (a-ast) concentration samples with flex read time and without flex read time. Samples were prepared using a serum pool and 4% human serum albumin (hsa). High samples were prepared in concentrations between ~20,000 u/l to ~200, and low samples were prepared in concentrations of ~100 to ~10. All serum pool and 4% hsa samples generated results within stated acceptance criteria. The serum pool and 4% hsa samples also generated results and/or flags appropriately based on the expected concentrations and no <5 u/l results were generated. A quality review of complaint activity for the a-ast assay was conducted and did not identify any adverse or non-statistical trends for patient results. The a-ast package insert was reviewed and was found to include information regarding dilutions exceeding linearity and flex rate linearity procedures. Based upon the data available and the results of the evaluation, no product deficiency was identified. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2011-00278 |
| MDR Report Key | 2114735 |
| Report Source | 01 |
| Date Received | 2011-06-06 |
| Date of Report | 2011-05-25 |
| Date Mfgr Received | 2011-10-21 |
| Device Manufacturer Date | 2010-11-19 |
| Date Added to Maude | 2011-06-07 |
| 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 | 0 |
| Event Location | 0 |
| 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 | 8479375120 |
| 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 | CLINICAL CHEMISTRY AST-ACTIVATED |
| Generic Name | FOR THE QUANTITATION OF ASPARTATE AMINOTRANSFERASE IN HUMAN SERUM OR PLASMA |
| Product Code | CIT |
| Date Received | 2011-06-06 |
| Catalog Number | 8L91-21 |
| Lot Number | 65900UN10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2011-06-06 |