MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2001-04-18 for IMMULITE 2000 H. PYLORI IGG L2KHEQ manufactured by Diagnostic Products Corp..
[188957]
Dpc received a report of discrepant results observed with immulite 2000 h. Pylori, kit lot l2kheq 104. A review of in-house quality control data indicated that the kit was performing within specifications. The discrepant samples were sent to dpc-la for testing. The discordant results were confirmed to be false positives. The investigation identified the root cause as the antigen used to coat the beat component. New procedures have been implemented to improve antigen conformance testing. The immulite h. Pylori and immulite 2000 h. Pylori assays are intended to be used as an aid in the diagnosis of h. Pylori infection in symptomatic individuals. Breath tests and endoscopic results are frequently used in conjunction with blood serological tests to confirm infection. Due to the prevalence of antibodies to h. Pylori in the general population, a positive h. Pylori result may not indicate an active infection or that the existing symptoms, if present, are the result of h. Pylori infection. Infection may have occurred some time in the past and may be unrelated to the reported symptoms. A positive h. Pylori test may lead to antibiotic treatment. Because it is not possible to identify those patients in which treatment will resolve the symptoms, all patients with symptoms are treated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017183-2001-00001 |
| MDR Report Key | 328278 |
| Report Source | 01,08 |
| Date Received | 2001-04-18 |
| Date Mfgr Received | 2001-03-21 |
| Device Manufacturer Date | 2000-09-01 |
| Date Added to Maude | 2001-04-25 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ROBERT DITULLIO, VICE PRESIDENT |
| Manufacturer Street | 5700 WEST 96TH ST. |
| Manufacturer City | LOS ANGELES CA * |
| Manufacturer Country | US |
| Manufacturer Postal | * |
| Manufacturer Phone | 3106458200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 H. PYLORI IGG |
| Generic Name | IN-VITRO DIAGNOSTIC TEST KIT |
| Product Code | LYR |
| Date Received | 2001-04-18 |
| Model Number | NA |
| Catalog Number | L2KHEQ |
| Lot Number | 104 |
| ID Number | NA |
| Device Expiration Date | 2001-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 317662 |
| Manufacturer | DIAGNOSTIC PRODUCTS CORP. |
| Manufacturer Address | 5700 WEST 96TH ST. LOS ANGELES CA 90045 US |
| Baseline Brand Name | IMMULITE 2000 H. PYLORI IGG |
| Baseline Generic Name | IVD TEST KIT |
| Baseline Model No | NA |
| Baseline Catalog No | L2KHEQ |
| Baseline ID | 104 |
| Baseline Device Family | IMMULITE 2000 IMMUNOASSAY KIT |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K000463 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-04-18 |