MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 1997-07-03 for TDXFLX DIGOXIN II REAGENT 9511-60 manufactured by Abbott Health Products, Inc..
[65413]
On 6/9/97 a female pt in icu had an initial digoxin result of 6:1 nm/l or 4. 76 ng/ml. The specimen was lipemic. A reassay of this sample after centrifuging and harvesting a less lipemic portion, resulted in a value of 2. 2 nm/l (1. 72 ng/ml). A reassay using the lipid-rich phase, confirmed the initial value.
Patient Sequence No: 1, Text Type: D, B5
[7761892]
Additional info indicates the pt was in intensive care for acute pyelonephritis. She was treated with endolipids 20% at 1:30 pm and at 2:30 pm blood draws were done. Code 81: no reagents or calibrators were returned. Investigation summary: the pt sample was highly lipemic, due to infusion of an intravenous fat emulsion prior to drawing a sample for determination of digoxin. The initial sample did not conform with the package insert recommendation concerning centrifugation to obtain a clear supernatant. The hospital performed the proper study to resolve the initial high digoxin result. Adequate centrifugation of the sample provided a more realistic digoxin concentration. It appears that digoxin, a hydrophobic molecule, has the potential to concentrate in lipid globules, and then be carried through the tdx/tdxflx digoxin assay following the pre-treatment step. The use of iv fat emulsion finds more extensive application in europe compared to north america and japan. The situation with this pt appears to be an infrequent, if not rare occurrence. Review of trend analysis showed no adverse trends. The device history record review showed all specifications were met. No corrective action is required. This is the final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2623532-1997-00018 |
| MDR Report Key | 103990 |
| Report Source | 01,06 |
| Date Received | 1997-07-03 |
| Date of Report | 1997-07-02 |
| Date of Event | 1997-06-09 |
| Device Manufacturer Date | 1997-02-01 |
| Date Added to Maude | 1997-07-10 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TDXFLX DIGOXIN II REAGENT |
| Generic Name | FPIA FOR THE MEASUREMENT OF DIGOXIN |
| Product Code | LCS |
| Date Received | 1997-07-03 |
| Model Number | NA |
| Catalog Number | 9511-60 |
| Lot Number | 26029Q100 |
| ID Number | NA |
| Device Expiration Date | 1998-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 102313 |
| Manufacturer | ABBOTT HEALTH PRODUCTS, INC. |
| Manufacturer Address | KM 58.0 CARRETERA 2 CRUCE DAVILA BARCELONETA PR 00617 US |
| Baseline Brand Name | TDXFLX DIGOXIN |
| Baseline Generic Name | FPIA FOR THE MEASUREMENT OF DIGOXIN |
| Baseline Model No | NA |
| Baseline Catalog No | 9511-60 |
| Baseline ID | NA |
| Baseline Device Family | TDXFLX DIGOXIN II |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K820154 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-07-03 |