MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-03-25 for CEP 8 (D8Z2) SPECTRUMGREEN PROBE 06J37-18 manufactured by Abbott Molecular, Inc..
[17607280]
Background: the cep 8 spectrumgreen (sg) asr probe kit, 20ul (list 06j37-018) is an analyte specific reagent (asr) containing a single vial of cep 8 spectrum green probe and a certificate of analysis (coa). Chromosome enumeration probes (cep) are chromosome-specific fish probes that hybridize to highly repetitive human satellite dna sequences, usually located near centromeres. Cep signals enable the identification and enumeration of human chromosomes in interphase and metaphase cells from fresh and archived samples. The label for cep 8 sg asr probe kit indicates it is an analyte specific reagent, and analytical and performance characteristics are not established. Issue: a customer reported receiving two kits of cep 8 sg asr probe (list 06j37-018, lot 440023), containing vysis cep 4 (alpha satellite) sg probe, 20ul,( part 32-112004 lot 438814), instead of the expected cep 8 probe. The customer did not use the product and returned both kits to abbott molecular for investigation. Impact: product functionality is impacted because use of cep 4 (sg) would not accurately enumerate chromosome 8. The cep 8 sg probe and the cep 4 sg probe both produce green signals near the centromere of their respective chromosomes. The presence of spectrum green signals near the centromere may lead the technician to conclude the test was performed correctly. If cep 8 positive controls are not run with patient samples, then the potential exists to generate incorrect results. Note: the cep 4 probe vials were correctly labeled to identify the actual contents of cep 4 probe.
Patient Sequence No: 1, Text Type: D, B5
[17646189]
An abbott molecular investigation confirmed this issue as a product malfunction. (b)(4) capa was opened as a result of this malfunction issue and is in progress. Abbott molecular is preparing an 806 field action to notify affected customers.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2013-00005 |
| MDR Report Key | 3019715 |
| Report Source | 07 |
| Date Received | 2013-03-25 |
| Date of Report | 2013-02-22 |
| Date of Event | 2013-02-22 |
| Date Mfgr Received | 2013-03-05 |
| Date Added to Maude | 2013-05-23 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JEAN LEETE |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 2243617274 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60018 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEP 8 (D8Z2) SPECTRUMGREEN PROBE |
| Generic Name | ANALYTE SPECIFIC REAGENTS |
| Product Code | MVU |
| Date Received | 2013-03-25 |
| Returned To Mfg | 2013-03-01 |
| Catalog Number | 06J37-18 |
| Lot Number | 440023 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 EAST TOUHY AVENUE DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-03-25 |