MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-06-03 for HEMOCCULT? ICT TEST DEVICE 395067 manufactured by Beckman Coulter.
[3527745]
The customer contacted beckman coulter (bec) reporting an increase in positive occult fecal blood test results generated on the hemoccult ict (immunochemical fecal occult blood test) device. It was reported by the customer that the color intensity of the positive test lines increased on the newer lots since (b)(6) 2012. The customer noted observing positive rates on the test device increased from approximately (b)(4) since (b)(6) 2012 with seven (7) different reagent lots (m207143, m208454, m210079, m211100, m212122, m212203, and m301418). This report documents lot # m208454 which was in use on (b)(6) 2012. As a result of this increase in positive test results a number of follow up colonoscopies were performed on patients, which were determined by the customer to be unnecessary. The customer did not provide actual patient test results or actual reported events where a patient or patients underwent unnecessary colonoscopy procedure(s).
Patient Sequence No: 1, Text Type: D, B5
[10789766]
The increase in positivity observed by the customer was confirmed through testing of the devices and review of previous batch records. Retain lots and lot m301418 returned by the customer were tested by bec with hemoglobin standards. The root cause of the increase in positivity is still under investigation, and is focused on the conjugate material used in the manufacture of the device. The following mdrs are related to this event, which documents the other reagent lot #s generated on different dates: 2050010-2013-00002, 2050010-2013-00003, 2050010-2013-00005, 2050010-2013-00006, 2050010-2013-00007, 2050010-2013-00008, 2050010-2013-00009.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050010-2013-00004 |
| MDR Report Key | 3141148 |
| Report Source | 01,05,06 |
| Date Received | 2013-06-03 |
| Date of Report | 2013-03-28 |
| Date of Event | 2012-11-05 |
| Date Mfgr Received | 2013-03-28 |
| Device Manufacturer Date | 2012-09-21 |
| Date Added to Maude | 2013-06-03 |
| 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 | MS DUNG NGUYEN |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 2470 FARADAY AVE. |
| Manufacturer City | CARLSBAD CA 92010 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCCULT? ICT TEST DEVICE |
| Generic Name | REAGENT, OCCULT BLOOD |
| Product Code | KHE |
| Date Received | 2013-06-03 |
| Model Number | HEMOCCULT? ICT |
| Catalog Number | 395067 |
| Lot Number | M208454 |
| Device Expiration Date | 2014-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BOULEVARD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-06-03 |