MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1996-08-30 for VITROS SALI SLIDES 800 1083 manufactured by Johnson &johnson Clinical Diagnostics.
[23986]
Pt sample mesured a salicylate of <1mg/dl (negative) using co salicylate slides. Result reported to physician. Physician requested a repeat of the test. A fresh pt sample was drawn and measured using the same cartridge of slides. Result was 3. 0 mg/dl (therapeutic range). A new cartridge was loaded and calibrated on instrument. Original sample and re-draw were run using new cartridge. Original sample gave 52mg/dl and re-draw gave 47 mg/dl. Both results are in the toxic range for salicylate. Physician stated that there were no adverse effects due to the misreported results.
Patient Sequence No: 1, Text Type: D, B5
[7773444]
A total of 15 slide cartridges (270 slides) were returned to co for evaluation. The slides were tested using a quality control fluid, lot number g1272. All 270 slides tested gave results between 12. 5 to 13. 2 mg/dl. All slides tested were within the expected quality control range. Product performed within specifications. Alleged failure could not be duplicated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319809-1996-00001 |
| MDR Report Key | 38954 |
| Report Source | 05,06 |
| Date Received | 1996-08-30 |
| Date of Report | 1996-08-06 |
| Date of Event | 1996-08-06 |
| Date Mfgr Received | 1996-08-06 |
| Device Manufacturer Date | 1996-02-01 |
| Date Added to Maude | 1996-09-23 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS SALI SLIDES |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | DKJ |
| Date Received | 1996-08-30 |
| Model Number | NA |
| Catalog Number | 800 1083 |
| Lot Number | 2206-0009-4400 |
| ID Number | NA |
| Device Expiration Date | 1997-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 40185 |
| Manufacturer | JOHNSON &JOHNSON CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DR ROCHESTER NY 14650 US |
| Baseline Brand Name | VITROS SALI SLIDES |
| Baseline Generic Name | IN VITRO DIAGNOSTIC (SALICYLATE) |
| Baseline Model No | NA |
| Baseline Catalog No | 800 1083 |
| Baseline ID | NA |
| Baseline Device Family | VITROS SALI SLIDES |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 14 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K902356 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-08-30 |