MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-09-29 for VP2000 2J11-01 30-144100 manufactured by Abbott Molecular.
[964656]
The tempurature display did not track the actual temperature of the basin of the vp2000 instrument. The display read low (0. 4c) and the actual temperature went over 100c. Vp2000 applications require the heater basins be controlled at temperature within +/-3c from the set temperature. Failure to meet these specifications could cause a delay in initiating a run or generation of uninterruptible results, which could cause a delay of patient results. This failure also introduces the hazard of incorrect diagnosis, which has been determined to be improbable (no increase in probability from that anticipated by the initial risk analysis). Under normal conditions of use, an operator can sustain third degree burns by contacting the heated surfaces. Normal conditions include excursions of several minutes at 73c (163f). This fault condition involves extended and uncontrolled excursions at or above 100c, and a failure of the mode of control for temperature monitoring. There have been two customer observations of this condition: none of these instances have resulted in a medical device report. However, abbot molecular (am) took a field action (field correction under (b) (4)) on september 12, 2008. Thus abbott molecular is filing this mdr due to this malfunction and abbott molecular's field action.
Patient Sequence No: 1, Text Type: D, B5
[8102030]
Additional model no. 2j11-04, 0j11-60. Additional catalog# 30-144101, 30-144102. Abbott molecular has sent out a customer letter advising customer to take the following actions: vp200 should be powered down when not in use and when the controlling computer is not in use. Liquid level in all heated basins should be checked periodically to ensure that there is adequate reagent present for slide processing and to keep the sensor probe immersed for accurate temperature sensing. If large, rapid and random fluctuations in indicated basin temperature occurs, the unit should be shut down and a field service representative be contacted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2008-00003 |
| MDR Report Key | 1181085 |
| Report Source | 07 |
| Date Received | 2008-09-29 |
| Date of Report | 2008-09-26 |
| Date of Event | 2008-09-12 |
| Date Mfgr Received | 2008-09-12 |
| Date Added to Maude | 2010-04-15 |
| 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 | MIRNA DIPANO, MANAGER |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 2243617807 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VP2000 |
| Generic Name | SLIDE SPECIMEN PROCESSOR |
| Product Code | KEY |
| Date Received | 2008-09-29 |
| Model Number | 2J11-01 |
| Catalog Number | 30-144100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR |
| Manufacturer Address | DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-29 |