MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-09 for TOMCAT INSTRUMENT ASY-07379 manufactured by Hologic, Inc.
[69872049]
The customer, (b)(6) called to report they observed that their tomcat instrument, sn (b)(4) sometimes fails to finish processing samples due to the e18-excessive sample volume error. . This issue has been identified on two other instruments (sn (b)(4)), however, no incorrect results have been reported to hologic on either instrument. Investigation identified the instrument sent the sample pipettor to the [? ]home' position in the incorrect z-axis location. This occurs when there is low friction within the x-axis, allowing the x-axis to move when the table or instrument is jolted. The effect of the sample pipettor arm moves approximately 10 mm lower than expected in the z-axis. This results in disposable tip of the pipettor making physical contact with the mucoid shelf during sample processing. Although there have been no reported incorrect results, this may lead to possible contamination of the current sample in process. In addition, the collision of the sample pipettor with the mucoid shelf may cause an unspecific amount of sample to release from the pipettor tip and disperse randomly around the instrument. This could also cause possible contamination of additional samples. Tomcat is a general purpose instrument.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2017-00010 |
| MDR Report Key | 6393941 |
| Date Received | 2017-03-09 |
| Date of Report | 2017-03-09 |
| Date of Event | 2017-02-08 |
| Date Mfgr Received | 2017-02-08 |
| Date Added to Maude | 2017-03-09 |
| 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 | MS JULIETTE BUSSE |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108799 |
| Manufacturer G1 | HOLOGIC, INC. |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TOMCAT INSTRUMENT |
| Generic Name | SAMPLE TRANSFER SYSTEM |
| Product Code | JQW |
| Date Received | 2017-03-09 |
| Catalog Number | ASY-07379 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 10210 GENETIC CENTER DR. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-09 |